IN.PACT Global Clinical Study

• Primary Endpoint Clinical Cohort [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure.
• Primary Endpoint Imaging Cohort [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Primary Patency within 12 months post-index procedure.
• Primary Safety Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.

• Major Adverse events [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
  - MAE (Major Adverse Events)is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
• Target lesion restenosis [ Time Frame: 30 days. 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]

  Imaging Cohort:

  -Duplex-defined binary restenosis of the target lesion at 12 months, or at the time of re-intervention.

The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia(CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death.

The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.

General inclusion Criteria:

• Age ≥ 18 years or minimum age as required by local regulations.
• Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4.
• Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.

General exclusion Criteria:

• High probability of non-adherence to CIP follow-up requirements.
• Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
• Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.