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.

  
  

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.