NCT02907203

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

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2017-10-10
• Primary completion: 2022-03-22
• Completion: 2022-03-22
• First posted: 2016-09-20
• Last updated: 2023-02-08
• Results posted: 2023-02-08

Locations

1 site across 1 country: Germany