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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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PAD

Intervention / Treatment
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* Device: Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Coated Balloon<br>Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. | Device: Drug Coated Balloon<br>* Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Lumen Loss (LLL) | Six month late lumen loss (LLL) is defined as the difference in minimum lumen diameter of the Target lesion between the time points immediately post-intervention and the 6-month follow-up angiography or at the time of a Clinically Driven Target Lesion Revascularization (CD TLR), whichever is earlier. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Freedom From Major Adverse Events | A composite 30-day safety endpoint of freedom from Major Adverse Events (MAE), defined as i) death, ii) Clinically-Driven Target Vessel Revascularization (CD TVR), or iii) amputation above the metatarsals, resulting from a vascular event, in the treated leg (Target limb amputation). | 30 days |