Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Artery Disease, Peripheral
- Femoropopliteal Artery Occlusion
- Peripheral Arterial Disease
- Peripheral Vascular Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03241459
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: William Gray, MD Lankenau Heart Group Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital Principal Investigator: Marianne Brodmann, MD Medical University Graz, Department of Internal Medicine
Get Well Soon