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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

March 27, 2012
July 21, 2014
March 2012
February 2014   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT01566461 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
IN.PACT Admiral Drug-Eluting Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Femoral Artery Stenosis
  • Popliteal Artery Stenosis
  • Femoral Artery Occlusion
  • Popliteal Artery Occlusion
  • 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
  • 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
  • Experimental: IN.PACT Admiral Drug-Eluting Balloon
    Paclitaxel drug-eluting angioplasty balloon
    Intervention: Device: IN.PACT Admiral Drug-Eluting Balloon
  • Active Comparator: Standard angioplasty balloon
    Standard angioplasty balloon without Paclitaxel drug-elution
    Intervention: Device: Standard angioplasty balloon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
June 2018
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01566461
10031540DOC
Yes
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Not Provided
Medtronic Endovascular
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP