Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter)

Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter) for Conformité Européene (CE) Mark Approval

This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic PAD.

The primary objective of the clinical investigation is to evaluate the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries (SFA/PA) of patients with symptomatic PAD.

The performance of the GORE® DCB Catheter is superior to a performance goal derived from literature reports of uncoated PTA balloons, measured six months after intervention.

Inclusion Criteria:

• PAD patients with Rutherford Class 2 - 4
• De novo or restenotic lesions, including total occlusions of the SFA/PA
• 1 lesion which may include one or more regions of luminal narrowing ≥70% with a total combined lesion length between 30 - 150mm and a reference vessel diameter of 4 - 6mm
• 1 patent tibial or peroneal artery

Exclusion Criteria:

• Surgical or endovascular access in the Target limb/vessel within the previous 30 days
• Prior treatment of the Target lesion with PTA within 90 days or any prior treatment with drug-coated balloon
• Prior treatment of the Target vessel with stenting or bypass
• Iliac artery inflow lesions that cannot be successfully treated during the Index procedure
• Acute or subacute thrombus or arterial aneurysm in Target limb
• Severe calcification that renders the Target lesion non-dilatable
• Acute or chronic renal dysfunction (serum creatinine ≥2.5 mg/dL)