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, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
  
  
• Primary Endpoint Imaging Cohort [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Primary Patency within 12 months post-index procedure, which is defined as: Freedom from clinically-driven TLR and • Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 Restenosis determined by either PSVR >2.4 as assessed by an independent DUS core lab or >50% stenosis as assessed by an independent angiographic core lab
  
  
• 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.
  
  

• MAEs [ 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 (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.
  
  
• All-cause mortality [ Time Frame: at 30 days, 6, 12, 24, 36, 48 and 60 months. ] [ Designated as safety issue: Yes ]
  
• Clinically-driven TLR [ Time Frame: at 30 days, 6, 24, 36, 48 and 60 months. ] [ Designated as safety issue: Yes ]
  
• Clinically-driven TVR [ Time Frame: at 30 days, 6, 12, 24, 36, 48 and 60 months. ] [ Designated as safety issue: Yes ]
  Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
  
  
• TLR [ Time Frame: at 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
  
• TVR [ Time Frame: at 6, 12, 24, 36, 48 and 60 months. ] [ Designated as safety issue: Yes ]
  
• Major target limb amputation [ Time Frame: at 30 days, 6, 12, 24, 36, 48 and 60 months. ] [ Designated as safety issue: Yes ]
  
• Time to first clinically-driven TLR [ Time Frame: through 60 months post-index procedure. ] [ Designated as safety issue: Yes ]
  
• Time to all-cause mortality [ Time Frame: through 60 months post-index procedure. ] [ Designated as safety issue: Yes ]
  
• Primary sustained clinical improvement [ Time Frame: at 6, 12, 24, 36 months. ] [ Designated as safety issue: Yes ]
  Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
  
  
• Secondary sustained clinical improvement [ Time Frame: at 6, 12, 24, 36 months. ] [ Designated as safety issue: Yes ]
  Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
  
  
• Immediate hemodynamic improvement [ Time Frame: at post-index procedure. ] [ Designated as safety issue: Yes ]
  Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9.
  
  
• Sustained hemodynamic improvement [ Time Frame: at 6, 12, 24, 36 months. ] [ Designated as safety issue: Yes ]
  Sustained hemodynamic improvement is defined as persistent improvement of ABI-values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
  
  
• Walking impairment evaluation by Walking Impairment Questionnaire (WIQ) [ Time Frame: at 6, 12, 24, 36 months. ] [ Designated as safety issue: Yes ]
  
• Walking distance as measured by 6 Minute Walk Test [ Time Frame: at 6, 12, 24, 36 months. ] [ Designated as safety issue: Yes ]
  
• Health related Quality of life scores (EQ5D) [ Time Frame: at 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
  
• Device success [ Time Frame: Index-procedure ] [ Designated as safety issue: Yes ]
  Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
  
  
• Clinical success [ Time Frame: prior to discharge ] [ Designated as safety issue: Yes ]
  Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
  
  
• Imaging cohort: Duplex-defined binary restenosis (PSVR > 2.0) of the target lesion [ Time Frame: at 12 months, or at the time of re-intervention. ] [ Designated as safety issue: Yes ]
  
• Imaging cohort: 21. Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion [ Time Frame: at 12 months, or at the time of re-intervention. ] [ Designated as safety issue: Yes ]
  

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.