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

NCT ID: NCT02907203

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-10
• Study Completion Date: 2022-03-22

Brief Summary

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

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.

Conditions

PAD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug Coated Balloon

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.

Group Type: EXPERIMENTAL

Drug Coated Balloon

Intervention Type: DEVICE

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.

Interventions

Drug Coated Balloon

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitats - Herzzentrum Freiburg

Bad Krozingen, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DCB 15-02

Identifier Type: -

Identifier Source: org_study_id