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

Completed

• Conditions: PAD
• Interventions: Device: Drug Coated Balloon

• Registration Number: NCT02907203
• Lead Sponsor: W.L.Gore & Associates

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.

Study Timeline

• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Study Start: 2017-10-10
• Primary Completion: 2022-03-22
• Study Completion: 2022-03-22
• Results First Submitted: 2022-11-11
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Results First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug Coated Balloon	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.

Primary Outcome Measures

Name	Time	Method
Late Lumen Loss (LLL)	Six months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Freedom From Major Adverse Events	30 days	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).

Trial Locations

Locations (1)

Universitats - Herzzentrum Freiburg; 🇩🇪 Bad Krozingen, Germany