MOTIV BTK Randomized Controlled Trial

Part of paid clinical trials in St. Helena, California.

Sponsor
REVA Medical, Inc.
Study ID
NCT05406622
Status
Recruiting
Apply to this trial

Conditions

  • Critical Limb Ischemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MOTIV Sirolimus-Eluting Bioresorbable Scaffold — DEVICE
    Participants will receive the MOTIV device
  • Percutaneous Transluminal Angioplasty (PTA) Device — DEVICE
    Participants will receive PTA treatment

Study Details

Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.

Key Dates

Start date
Jun 10, 2022
Status verified
Apr 2025
Primary completion
Sep 30, 2025
Completion
Mar 31, 2029

Study Design

Enrollment
292 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MOTIV Sirolimus-Eluting Bioresorbable Scaffold
    Participants who receive the MOTIV device will be included in this arm
  • Active Comparator: Percutaneous Transluminal Angioplasty (PTA)
    Participants who receive PTA treatment will be included in this arm

Primary Outcome Measure

Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency [ Time Frame: 6 Months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Adventist HealthSt. HelenaCalifornia94574
Ehrin Armstrong
Ehrin Armstrong, MD (PRINCIPAL_INVESTIGATOR)
UnityPoint Health Trinity Bettendorf HospitalBettendorfIowa52722
Gail Shammas
[email protected]
Nicolas Shammas, MD (PRINCIPAL_INVESTIGATOR)
Amit Bahia, MD (SUB_INVESTIGATOR)
Cardiovascular Medicine PCDavenportIowa52803
Gail Shammas
[email protected]
Nicolas Shammas, MD (PRINCIPAL_INVESTIGATOR)
Amit Bahia, MD (SUB_INVESTIGATOR)

Find similar trials in St. Helena, CA

By research site
Adventist Health· St. Helena, CAUnityPoint Health Trinity Bettendorf Hospital· Bettendorf, IACardiovascular Medicine PC· Davenport, IA

Related Studies