Safety and Efficacy of the SurVeil Drug-Coated Balloon

  • STATUS
    Not Recruiting
  • End date
    Apr 19, 2024
  • participants needed
    446
  • sponsor
    SurModics, Inc.
Updated on 7 July 2022
Investigator
Shawn K Fuller, BS
Primary Contact
St. Elizabeth's Medical Center (2.0 mi away) Contact
+62 other location
arteriopathy
angiography
stenosis
paclitaxel
peripheral arterial diseases
transluminal angioplasty

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.

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.

Details
Condition Peripheral vascular disease, peripheral arterial disease, Femoropopliteal Artery Occlusion
Treatment Surmodics SurVeil DCB, Medtronic IN.PACT Admiral DCB
Clinical Study IdentifierNCT03241459
SponsorSurModics, Inc.
Last Modified on7 July 2022

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