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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01566461
First received: March 27, 2012
Last updated: July 17, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Femoral Artery Stenosis
Popliteal Artery Stenosis
Femoral Artery Occlusion
Popliteal Artery Occlusion
Device: Drug-Coated Balloon (DCB)
Device: PTA Balloon: Balloon Angioplasty
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Primary Patency [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization (TLR) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Time to First Clinically Driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Thrombosis at the Target Lesion [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Primary Sustained Clinical Improvement [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.

  • Secondary Sustained Clinical Improvement [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Freedom from target amputation and increase in Rutherford class.

  • Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D) [ Time Frame: 12 month ] [ Designated as safety issue: No ]

    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) [ Time Frame: From baseline to 12 month ] [ Designated as safety issue: No ]
    Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.

  • Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ) [ Time Frame: 12 month ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.

  • Clinical Success [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Days of hospitalization from procedure through 12 month.


Enrollment: 331
Study Start Date: March 2012
Estimated Study Completion Date: June 2018
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug-Coated Balloon (DCB)
IN.PACT Admiral: Balloon Angioplasty
Device: Drug-Coated Balloon (DCB)
Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
Active Comparator: Standard PTA
Standard Percutaneous Balloon Angioplasty (PTA) Balloon: Balloon Angioplasty
Device: PTA Balloon: Balloon Angioplasty
Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566461

Locations
United States, California
Washington Hospital
Fremont, California, United States, 94538
University of California, Davis
Sacramento, California, United States, 95817
United States, Hawaii
Kaiser Permanente Hawaii
Honolulu, Hawaii, United States, 96819
Sponsors and Collaborators
Medtronic Endovascular
  More Information

No publications provided by Medtronic Endovascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01566461     History of Changes
Other Study ID Numbers: 10031540DOC
Study First Received: March 27, 2012
Results First Received: February 18, 2015
Last Updated: July 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Drug-Coated Angioplasty Balloon
Drug Coated Angioplasty Balloon
Peripheral Artery Disease
Experimental
Percutaneous Transluminal Angioplasty (PTA)

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Constriction, Pathologic
Cardiovascular Diseases
Pathological Conditions, Anatomical
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2015