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IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA) (INPACT SFA II)

Primary Purpose

Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drug-Coated Balloon (DCB)
PTA Balloon: Balloon Angioplasty
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Artery Stenosis focused on measuring Drug-Coated Angioplasty Balloon, Drug Coated Angioplasty Balloon, Peripheral Artery Disease, Experimental, Percutaneous Transluminal Angioplasty (PTA)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: > or equal to 18 years and < or equal to 85 years
  • Documented ischemia with Rutherford classification 2, 3, or 4
  • Target lesion in the SFA and/or PPA

  • Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria:

    1. 70 - 99% occlusion by visual estimate with lesion length > or equal to 4 cm and < or equal to 18 cm
    2. 100% occlusion by visual estimate with lesion length < or equal to 10 cm
    3. Combination lesions must have a total lesion length of > or equal to 4 cm and < or equal to 18 cm with an occluded segment that is < or equal to 10 cm (by visual estimate)
  • Target vessel diameter > or equal to 4 mm and < or equal to 7 mm
  • Angiographic evidence of adequate distal run-off to the ankle
  • Able to walk without assistive devices

Exclusion Criteria:

  • Stroke or heart attack within 3 months prior to enrollment
  • Enrolled in another investigational drug, device or biologic study
  • Any surgical procedure or intervention performed within 30 days prior to or post index procedure
  • SFA or PPA disease in the opposite leg that requires treatment at the index procedure
  • Failure to successfully cross the target lesion
  • Angiographic evidence of severe calcification
  • Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices)
  • Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
  • Chronic kidney disease

Sites / Locations

  • Washington Hospital
  • Kaiser Permanente Hawaii

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug-Coated Balloon (DCB)

Standard PTA

Arm Description

IN.PACT Admiral: Balloon Angioplasty

Standard Percutaneous Balloon Angioplasty (PTA) Balloon: Balloon Angioplasty

Outcomes

Primary Outcome Measures

Primary Patency
Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.
Primary Safety Composite
Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.

Secondary Outcome Measures

Major Adverse Event (MAE) Composite
Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.
All-cause Death
Target Vessel Revascularization (TVR)
Target Lesion Revascularization (TLR)
Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)
Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post procedure baseline.
Major Target Limb Amputation
Thrombosis at the Target Lesion
Primary Sustained Clinical Improvement
Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.
Secondary Sustained Clinical Improvement
Freedom from target amputation and increase in Rutherford class.
Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)
Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)
Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)
Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used. EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'.
Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)
Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.
Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)
Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication. Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment).
Device Success
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).
Procedural Success
Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.
Clinical Success
Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.
Days of Hospitalization Due to the Index Lesion
Days of hospitalization from procedure through 12 month.

Full Information

First Posted
March 27, 2012
Last Updated
January 29, 2019
Sponsor
Medtronic Endovascular
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1. Study Identification

Unique Protocol Identification Number
NCT01566461
Brief Title
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
Acronym
INPACT SFA II
Official Title
Randomized Trial of IN.PACT (Paclitaxel) Admiral Drug-Coated Balloon (DCB) vs. Standard Percutaneous Transluminal Angioplasty (PTA) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
May 2018 (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 the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.
Detailed Description
The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with congruent design and protocol. Aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
Keywords
Drug-Coated Angioplasty Balloon, Drug Coated Angioplasty Balloon, Peripheral Artery Disease, Experimental, Percutaneous Transluminal Angioplasty (PTA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug-Coated Balloon (DCB)
Arm Type
Experimental
Arm Description
IN.PACT Admiral: Balloon Angioplasty
Arm Title
Standard PTA
Arm Type
Active Comparator
Arm Description
Standard Percutaneous Balloon Angioplasty (PTA) Balloon: Balloon Angioplasty
Intervention Type
Device
Intervention Name(s)
Drug-Coated Balloon (DCB)
Intervention Description
Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
Intervention Type
Device
Intervention Name(s)
PTA Balloon: Balloon Angioplasty
Intervention Description
Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
Primary Outcome Measure Information:
Title
Primary Patency
Description
Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.
Time Frame
12 month
Title
Primary Safety Composite
Description
Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Major Adverse Event (MAE) Composite
Description
Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.
Time Frame
12 month
Title
All-cause Death
Time Frame
12 month
Title
Target Vessel Revascularization (TVR)
Time Frame
12 month
Title
Target Lesion Revascularization (TLR)
Time Frame
12 month
Title
Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)
Description
Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post procedure baseline.
Time Frame
12 month
Title
Major Target Limb Amputation
Time Frame
12 month
Title
Thrombosis at the Target Lesion
Time Frame
12 month
Title
Primary Sustained Clinical Improvement
Description
Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.
Time Frame
12 month
Title
Secondary Sustained Clinical Improvement
Description
Freedom from target amputation and increase in Rutherford class.
Time Frame
12 month
Title
Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)
Time Frame
12 month
Title
Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)
Time Frame
12 month
Title
Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)
Description
Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used. EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'.
Time Frame
12 month
Title
Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)
Description
Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.
Time Frame
From baseline to 12 month
Title
Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)
Description
Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication. Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment).
Time Frame
12 month
Title
Device Success
Description
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).
Time Frame
Day 1
Title
Procedural Success
Description
Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.
Time Frame
Day 1
Title
Clinical Success
Description
Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.
Time Frame
Day 1
Title
Days of Hospitalization Due to the Index Lesion
Description
Days of hospitalization from procedure through 12 month.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: > or equal to 18 years and < or equal to 85 years Documented ischemia with Rutherford classification 2, 3, or 4 Target lesion in the SFA and/or PPA Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria: 70 - 99% occlusion by visual estimate with lesion length > or equal to 4 cm and < or equal to 18 cm 100% occlusion by visual estimate with lesion length < or equal to 10 cm Combination lesions must have a total lesion length of > or equal to 4 cm and < or equal to 18 cm with an occluded segment that is < or equal to 10 cm (by visual estimate) Target vessel diameter > or equal to 4 mm and < or equal to 7 mm Angiographic evidence of adequate distal run-off to the ankle Able to walk without assistive devices Exclusion Criteria: Stroke or heart attack within 3 months prior to enrollment Enrolled in another investigational drug, device or biologic study Any surgical procedure or intervention performed within 30 days prior to or post index procedure SFA or PPA disease in the opposite leg that requires treatment at the index procedure Failure to successfully cross the target lesion Angiographic evidence of severe calcification Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices) Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure Chronic kidney disease
Facility Information:
Facility Name
Washington Hospital
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Kaiser Permanente Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36137674
Citation
Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.
Results Reference
derived
PubMed Identifier
31543165
Citation
Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.
Results Reference
derived
PubMed Identifier
31195825
Citation
Laird JA, Schneider PA, Jaff MR, Brodmann M, Zeller T, Metzger DC, Krishnan P, Scheinert D, Micari A, Wang H, Masters M, Tepe G. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. 2019 Jun;12(6):e007702. doi: 10.1161/CIRCINTERVENTIONS.118.007702. Epub 2019 Jun 14.
Results Reference
derived
PubMed Identifier
30690141
Citation
Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25. Erratum In: J Am Coll Cardiol. 2019 Feb 28;:
Results Reference
derived
PubMed Identifier
29326153
Citation
Schneider PA, Laird JR, Tepe G, Brodmann M, Zeller T, Scheinert D, Metzger C, Micari A, Sachar R, Jaff MR, Wang H, Hasenbank MS, Krishnan P; IN.PACT SFA Trial Investigators. Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial. Circ Cardiovasc Interv. 2018 Jan;11(1):e005891. doi: 10.1161/CIRCINTERVENTIONS.117.005891.
Results Reference
derived
PubMed Identifier
26476467
Citation
Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14.
Results Reference
derived
PubMed Identifier
25472980
Citation
Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, Metzger C, Scheinert D, Zeller T, Cohen DJ, Snead DB, Alexander B, Landini M, Jaff MR; IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015 Feb 3;131(5):495-502. doi: 10.1161/CIRCULATIONAHA.114.011004. Epub 2014 Dec 3.
Results Reference
derived

Learn more about this trial

IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)

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