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Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery. (MOBILITY AP)

Primary Purpose

Peripheral Vascular Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Absolute Pro™ Peripheral Self-Expanding Stent System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Atherosclerosis, Peripheral artery disease, Peripheral vascular disease, PAD, Claudication, Peripheral Arterial Occlusive Disease, Stent, PAOD, PVD

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Clinical Inclusion Criteria:

  1. Subject must be at least 18 and < 90 years of age.
  2. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form.
  3. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
  4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).
  5. Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months.

Angiographic Inclusion Criteria

  1. Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side).
  2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion)
  3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis
  4. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro)
  5. Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm
  6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro)
  7. On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis.
  8. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite).
  9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite).

Clinical Exclusion Criteria

  1. Subject is unable to walk.
  2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery.
  3. Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver).
  4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6.
  5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s).
  6. Subject has elevated serum creatinine > 2.0 mg/dl.
  7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl).
  8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days.
  9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk.
  10. Subject has unstable angina defined as rest angina with ECG changes.
  11. Subject has a groin infection, or an acute systemic infection that is currently under treatment.
  12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
  13. Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure.
  14. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 2 years).
  15. Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints.
  16. Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits.
  17. If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
  18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®).
  19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.
  20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.
  21. If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
  22. Requirement of general anesthesia or spinal block for the procedure.
  23. Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic.
  24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion.
  25. Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary.
  26. Target lesion is in an iliac artery that has been previously stented.

Angiographic Exclusion Criteria

  1. Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion.
  2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion
  3. Target lesion is within or adjacent to an aneurysm.
  4. Lesion is located within or beyond a vessel that contains a bypass graft.
  5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.
  6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3cm.
  7. Lesion extends beyond the inguinal ligament.
  8. Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies.
  9. Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure.
  10. On the treatment side(s), subject is without patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis.
  11. Requirement for > 1 stent to treat full length of lesion.

Sites / Locations

  • Abbott Vascular

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Absolute Pro™ Peripheral Self-Expanding Stent System

Arm Description

Arm includes both Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems

Outcomes

Primary Outcome Measures

Major Adverse Event (MAE) Rate
Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).

Secondary Outcome Measures

Device Success
On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).
Technical Success
Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of < 30% by QA or as reported by the investigator, if QA is not available.
Procedure Success
Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ)
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ)
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Restenosis
Defined as ≥ 50% stenosis at follow-up.
Restenosis
Defined as ≥ 50% stenosis at follow-up.
Restenosis
Defined as ≥ 50% stenosis at follow-up.
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Kaplan-Meier Estimate of Freedom From Embolic Events
Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Kaplan-Meier Estimate of Freedom From Embolic Events
Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery
Kaplan-Meier Estimate of Freedom From Embolic Events
Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery
Kaplan-Meier Estimate of Freedom From Embolic Events
Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery
Stent Thrombosis
Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Full Information

First Posted
February 12, 2009
Last Updated
May 14, 2015
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00844532
Brief Title
Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.
Acronym
MOBILITY AP
Official Title
A Prospective, Non-randomized, 2 Arm (AP Arm & Omni-Link Elite [OE] Arm-separately Posted as: NCT01396525), Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery. CAUTION: The Omnilink Elite™ Peripheral Balloon-expandable Stent System is an Investigational Device. Limited by Federal (U.S.) Law to Investigational Use Only.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
Keywords
Atherosclerosis, Peripheral artery disease, Peripheral vascular disease, PAD, Claudication, Peripheral Arterial Occlusive Disease, Stent, PAOD, PVD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Absolute Pro™ Peripheral Self-Expanding Stent System
Arm Type
Experimental
Arm Description
Arm includes both Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems
Intervention Type
Device
Intervention Name(s)
Absolute Pro™ Peripheral Self-Expanding Stent System
Intervention Description
Absolute Pro™ Peripheral Self-Expanding Stent System: Devices include both Absolute Pro™ and Absolute Pro™ LL Peripheral Self-Expanding Stent Systems. It is indicated for the treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Primary Outcome Measure Information:
Title
Major Adverse Event (MAE) Rate
Description
Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Device Success
Description
On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).
Time Frame
acute: from beginning of index procedure to end of index procedure.
Title
Technical Success
Description
Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of < 30% by QA or as reported by the investigator, if QA is not available.
Time Frame
acute: from beginning of index procedure to end of index procedure.
Title
Procedure Success
Description
Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.
Time Frame
Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner
Title
Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame
Pre-procedure
Title
Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame
Post-procedure
Title
Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame
1 month
Title
Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame
9 months
Title
Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame
2 years
Title
Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame
3 years
Title
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time Frame
Post-procedure
Title
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time Frame
1 month
Title
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time Frame
9 months
Title
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time Frame
2 years
Title
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
Description
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time Frame
3 years
Title
Walking Impairment Questionaire Scores
Description
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Time Frame
Pre-procedure
Title
Walking Impairment Questionaire Scores
Description
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Time Frame
1 month
Title
Walking Impairment Questionaire Scores
Description
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Time Frame
9 months
Title
Walking Impairment Questionaire Scores
Description
Measured by the Walking Impairment Questionnaire (WIQ)
Time Frame
2 years
Title
Walking Impairment Questionaire Scores
Description
Measured by the Walking Impairment Questionnaire (WIQ)
Time Frame
3 years
Title
Rutherford Becker Clinical Category for the Treated Limb(s)
Description
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time Frame
Pre-Procedure
Title
Rutherford Becker Clinical Category for the Treated Limb(s)
Description
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time Frame
1 month
Title
Rutherford Becker Clinical Category for the Treated Limb(s)
Description
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time Frame
9 months
Title
Rutherford Becker Clinical Category for the Treated Limb(s)
Description
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time Frame
2 years
Title
Rutherford Becker Clinical Category for the Treated Limb(s)
Description
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time Frame
3 years
Title
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Description
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time Frame
Between baseline and 1 month
Title
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Description
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time Frame
Between baseline and 9 months
Title
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Description
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time Frame
Between baseline and 2 years
Title
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Description
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time Frame
Between baseline and 3 years
Title
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Description
Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time Frame
1 month and 9 months
Title
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Description
Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time Frame
18 months
Title
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Description
Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time Frame
2 years
Title
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Description
Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time Frame
3 years
Title
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Time Frame
1 month and 9 months
Title
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Time Frame
18 months
Title
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Time Frame
2 years
Title
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Time Frame
3 years
Title
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)
Time Frame
1 month and 9 months
Title
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)
Time Frame
18 months
Title
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)
Time Frame
2 years
Title
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)
Time Frame
3 years
Title
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Description
Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time Frame
1 month and 9 months
Title
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Description
Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time Frame
18 months
Title
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Description
Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time Frame
2 years
Title
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Description
Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time Frame
3 years
Title
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Description
Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time Frame
1 month and 9 months
Title
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Description
Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time Frame
18 months
Title
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Description
Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time Frame
2 years
Title
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Description
Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time Frame
3 years
Title
Primary Stent Patency
Description
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Time Frame
1 month
Title
Primary Stent Patency
Description
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Time Frame
9 months
Title
Primary Stent Patency
Description
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Time Frame
2 years
Title
Primary Stent Patency
Description
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Time Frame
3 years
Title
Restenosis
Description
Defined as ≥ 50% stenosis at follow-up.
Time Frame
9 months
Title
Restenosis
Description
Defined as ≥ 50% stenosis at follow-up.
Time Frame
2 years
Title
Restenosis
Description
Defined as ≥ 50% stenosis at follow-up.
Time Frame
3 years
Title
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Time Frame
1 month and 9 months
Title
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Time Frame
18 months
Title
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Time Frame
2 years
Title
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Description
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Time Frame
3 years
Title
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Description
The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time Frame
1 month and 9 months
Title
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Description
The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time Frame
18 months
Title
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Description
The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Description
The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time Frame
3 years
Title
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Description
Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Time Frame
1 month and 9 months
Title
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Description
Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Time Frame
18 months
Title
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Description
Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Description
Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Time Frame
3 years
Title
Kaplan-Meier Estimate of Freedom From Embolic Events
Description
Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time Frame
1 month and 9 months
Title
Kaplan-Meier Estimate of Freedom From Embolic Events
Description
Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery
Time Frame
18 months
Title
Kaplan-Meier Estimate of Freedom From Embolic Events
Description
Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery
Time Frame
2 years
Title
Kaplan-Meier Estimate of Freedom From Embolic Events
Description
Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery
Time Frame
3 years
Title
Stent Thrombosis
Description
Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.
Time Frame
1 month
Title
Changes in Quality of Life Measures: Physical Component Summary
Description
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame
Baseline and 1 month
Title
Changes in Quality of Life Measures: Physical Component Summary
Description
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame
Baseline and 9 months
Title
Changes in Quality of Life Measures: Physical Component Summary
Description
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame
Baseline and 2 years
Title
Changes in Quality of Life Measures: Physical Component Summary
Description
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame
Baseline and 3 years
Title
Changes in Quality of Life Measures: Mental Component Summary
Description
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame
Baseline and 1 month
Title
Changes in Quality of Life Measures: Mental Component Summary
Description
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame
Baseline and 9 months
Title
Changes in Quality of Life Measures: Mental Component Summary
Description
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame
Baseline and 2 years
Title
Changes in Quality of Life Measures: Mental Component Summary
Description
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame
Baseline and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Clinical Inclusion Criteria: Subject must be at least 18 and < 90 years of age. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4). Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months. Angiographic Inclusion Criteria Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side). Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion) External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro) Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro) On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite). Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite). Clinical Exclusion Criteria Subject is unable to walk. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery. Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver). Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s). Subject has elevated serum creatinine > 2.0 mg/dl. Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl). Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk. Subject has unstable angina defined as rest angina with ECG changes. Subject has a groin infection, or an acute systemic infection that is currently under treatment. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity. Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 2 years). Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints. Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits. If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®). Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy. If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication. Requirement of general anesthesia or spinal block for the procedure. Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion. Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary. Target lesion is in an iliac artery that has been previously stented. Angiographic Exclusion Criteria Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion Target lesion is within or adjacent to an aneurysm. Lesion is located within or beyond a vessel that contains a bypass graft. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3cm. Lesion extends beyond the inguinal ligament. Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies. Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure. On the treatment side(s), subject is without patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis. Requirement for > 1 stent to treat full length of lesion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony S. Das, MD
Organizational Affiliation
Presbyterian Heart Institute, Dallas, TX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manish Mehta, MD, MPH
Organizational Affiliation
Albany Medical Center, Albany, NY.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Vascular
City
Santa Clara
State/Province
California
ZIP/Postal Code
95054
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.

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