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

PAD Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02907203
Study type Interventional
Source W.L.Gore & Associates
Contact
Status Completed
Phase
Start date October 10, 2017
Completion date March 22, 2022
View Details
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