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Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE) (INTENSE)

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Scuba Iliac Stent System
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Iliac Artery Stenting, Peripheral Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Presence of de novo or restenotic lesion(s), located in the common or external iliac artery with ≥50% stenosis
  • Subject has lifestyle limiting claudication or rest pain, (Rutherford- Becker scale [clinical category] 2, 3, or 4)
  • Target vessel reference diameter is 5mm - 10mm by visual assessment
  • Target lesion length < 130mm
  • Subject has angiographic evidence of a patent femoral outflow artery in the target limb
  • Subject has provided written informed consent
  • Subject is able and willing to adhere to required follow-up visits and testing

Exclusion Criteria:

  • Subject has lesions in the Common Femoral Artery (CFA), Profundal Femoral Artery (PFA), or Superficial Femoral Artery (SFA) that would require a staged procedure within 30 days of the index procedure (either before or after)
  • Target lesion(s) has adjacent, acute thrombus
  • Target lesion(s) is highly calcified or was previously treated with a stent
  • Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery
  • Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion
  • Subject has a post-surgical stenosis and anastomotic suture treatments in the native iliac vessel
  • Subject has a vascular graft previously implanted in the native iliac vessel
  • Subject has tissue loss - Rutherford-Becker clinical category 5 or 6
  • History of neutropenia (WBC <3,000/mm3), coagulopathy, or thrombocytopenia (platelet count <80,000/uL)
  • International Normalized ratio (INR) greater than 1.5
  • Serum creatinine greater than 2.5 mg/dL
  • Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0 g/dL) that cannot be corrected
  • Subject is participating in an investigational study of a new drug, biologic, or device at the same time of study screening

Sites / Locations

  • Baptist Hospital of Miami
  • Greenville Hospital System
  • Hamburg University Cardiovascular Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Scuba Iliac Stent System

Arm Description

Device: Scuba™ iliac stent

Outcomes

Primary Outcome Measures

Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.
The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.

Secondary Outcome Measures

Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion)
The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent.
Device Success
The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.
Procedural Success
The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE).
Clinical Success
Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit.
Clinical Success
Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.
Clinical Success
Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.
Patency - Primary
Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.
Patency - Primary Assisted
Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months.
Patency - Secondary
Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months.
Patency - Primary
Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.
Patency - Primary Assisted
Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months.
Patency - Secondary
Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months.
Target Limb Revascularization
Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.
Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)
Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.
Death
Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established.
Target Limb Loss
Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe.

Full Information

First Posted
April 10, 2009
Last Updated
January 28, 2016
Sponsor
Medtronic Endovascular
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1. Study Identification

Unique Protocol Identification Number
NCT00880230
Brief Title
Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)
Acronym
INTENSE
Official Title
INTENSE: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.
Detailed Description
Interventional revascularization strategies for peripheral arterial disease currently available include both surgical and endovascular approaches such as percutaneous transluminal angioplasty (PTA), either as a stand-alone procedure or with the placement of a stent. Cobalt-chromium (CoCr) is an alloy that has been used safely in the manufacture of surgical implants for use in contact with blood, soft tissue and bone for over 10 years. This study will evaluate the SCUBA™ peripheral balloon-expandable cobalt chromium tent system in iliac arteries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
Iliac Artery Stenting, Peripheral Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scuba Iliac Stent System
Arm Type
Experimental
Arm Description
Device: Scuba™ iliac stent
Intervention Type
Device
Intervention Name(s)
Scuba Iliac Stent System
Other Intervention Name(s)
Scuba
Intervention Description
The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Primary Outcome Measure Information:
Title
Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.
Description
The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.
Time Frame
In-hospital and 9 Months
Secondary Outcome Measure Information:
Title
Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion)
Description
The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent.
Time Frame
30 Days
Title
Device Success
Description
The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.
Time Frame
At time of deployment
Title
Procedural Success
Description
The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE).
Time Frame
Up to the moment the catheter sheath introducer has been removed
Title
Clinical Success
Description
Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit.
Time Frame
30 Days
Title
Clinical Success
Description
Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.
Time Frame
6 Months
Title
Clinical Success
Description
Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.
Time Frame
9 Months
Title
Patency - Primary
Description
Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.
Time Frame
6 Months
Title
Patency - Primary Assisted
Description
Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months.
Time Frame
6 Months
Title
Patency - Secondary
Description
Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months.
Time Frame
6 Months
Title
Patency - Primary
Description
Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.
Time Frame
9 Months
Title
Patency - Primary Assisted
Description
Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months.
Time Frame
9 Months
Title
Patency - Secondary
Description
Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months.
Time Frame
9 Months
Title
Target Limb Revascularization
Description
Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.
Time Frame
9 Months
Title
Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)
Description
Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.
Time Frame
9 Months
Title
Death
Description
Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established.
Time Frame
9 Months
Title
Target Limb Loss
Description
Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe.
Time Frame
9 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of de novo or restenotic lesion(s), located in the common or external iliac artery with ≥50% stenosis Subject has lifestyle limiting claudication or rest pain, (Rutherford- Becker scale [clinical category] 2, 3, or 4) Target vessel reference diameter is 5mm - 10mm by visual assessment Target lesion length < 130mm Subject has angiographic evidence of a patent femoral outflow artery in the target limb Subject has provided written informed consent Subject is able and willing to adhere to required follow-up visits and testing Exclusion Criteria: Subject has lesions in the Common Femoral Artery (CFA), Profundal Femoral Artery (PFA), or Superficial Femoral Artery (SFA) that would require a staged procedure within 30 days of the index procedure (either before or after) Target lesion(s) has adjacent, acute thrombus Target lesion(s) is highly calcified or was previously treated with a stent Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion Subject has a post-surgical stenosis and anastomotic suture treatments in the native iliac vessel Subject has a vascular graft previously implanted in the native iliac vessel Subject has tissue loss - Rutherford-Becker clinical category 5 or 6 History of neutropenia (WBC <3,000/mm3), coagulopathy, or thrombocytopenia (platelet count <80,000/uL) International Normalized ratio (INR) greater than 1.5 Serum creatinine greater than 2.5 mg/dL Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0 g/dL) that cannot be corrected Subject is participating in an investigational study of a new drug, biologic, or device at the same time of study screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce H Gray, DO
Organizational Affiliation
Greeville Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barry T Katzen, MD
Organizational Affiliation
Baptist Health South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Hamburg University Cardiovascular Center
City
Hamburg
ZIP/Postal Code
22527
Country
Germany

12. IPD Sharing Statement

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Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)

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