IN.PACT Admiral Drug-Coated 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-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)

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.

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.

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