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Safety and Efficacy of the SurVeil™ Drug-Coated Balloon — TRANSCEND  

Peripheral Arterial Disease Clinical Trial

Official title:
Randomized & Controlled Noninferiority Trial to Evaluate Safety & Clinical Efficacy of SurVeil™ Drug-Coated Balloon (DCB) iN Treatment of Subjects With Stenotic Lesions of Femoropopliteal Artery Compared to Medtronic IN.PACT® Admiral® DCB

Clinical Trial Summary

To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.

Clinical Trial Description

TRANSCEND is a prospective, multi-center, single-blind, randomized, controlled, noninferiority clinical trial. The trial will randomize approximately 446 subjects with symptomatic PAD due to stenoses of the femoral and/or popliteal arteries. Subjects meeting eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the IN.PACT Admiral DCB, and followed for 60 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03241459
Study type Interventional
Source SurModics, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date October 23, 2017
Completion date October 2024
View Details
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