IN.PACT Admiral Drug-Eluting 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 21, 2014
Last verified: July 2014
  Purpose

The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-eluting balloon 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: IN.PACT Admiral Drug-Eluting Balloon
Device: Standard angioplasty balloon
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-Eluting Balloon (DEB) 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:
  • Efficacy: Primary patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Primary patency is defined as freedom from clinically driven target lesion revascularization (TLR) and freedom from restenosis as determined by duplex ultrasound (DUS)

  • Safety: Composite of freedom from device and procedure-related death through 30 days post procedure, and freedom from both target limb major amputation and clinically-driven target vessel revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Target Lesion Revascularization (TLR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Rate of target lesion revascularizations

  • Rutherford Classification [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    An improvment shift in the Rutherford classification of at least on class in amputation and TVR-free surviving subjects

  • Walking Distance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Change in walking distance from baseline as assessed by 6 Minute Walk Test

  • Binary Restenosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion at 24 months or at the time of reintervention


Estimated Enrollment: 450
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: IN.PACT Admiral Drug-Eluting Balloon
Paclitaxel drug-eluting angioplasty balloon
Device: IN.PACT Admiral Drug-Eluting Balloon
Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Eluting Balloon Arm or to the standard angioplasty balloon Arm
Active Comparator: Standard angioplasty balloon
Standard angioplasty balloon without Paclitaxel drug-elution
Device: Standard angioplasty balloon
Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Eluting Balloon Arm or to the standard angioplasty balloon Arm

  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

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01566461     History of Changes
Other Study ID Numbers: 10031540DOC
Study First Received: March 27, 2012
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 20, 2014