A Prospective, Multicenter, Single Blind, Randomized Controlled Trial Evaluating the Safety and Effectiveness of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold Compared With Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions
REVA Medical, Inc.
Summary
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Clinical Inclusion Criteria Subjects must meet all of the following criteria to be eligible for enrollment in the trial: 1. Subject is at least 18 years of age. 2. Subject presents with symptomatic CLI classified as Rutherford category 4 or 5. 3. Subject agrees to comply with all-protocol specified procedures and follow-up assessments. 4. Subject or subject's legal representative signs an IRB/EC approved informed consent form prior to study participation. Angiographic Inclusion Criteria Subjects must meet the following criteria to be eligible for participation in the s…
Interventions
- DeviceMOTIV Sirolimus-Eluting Bioresorbable Scaffold
Participants will receive the MOTIV device
- DevicePercutaneous Transluminal Angioplasty (PTA) Device
Participants will receive PTA treatment
Locations (4)
- Adventist HealthSt. Helena, California
- UnityPoint Health Trinity Bettendorf HospitalBettendorf, Iowa
- Cardiovascular Medicine PCDavenport, Iowa
- University LeipzigLeipzig