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MOTIV BTK Randomized Controlled Trial

NCT05406622 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2025-04-02

No results posted yet for this study

Summary

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

Conditions

  • Critical Limb Ischemia

Interventions

DEVICE

MOTIV Sirolimus-Eluting Bioresorbable Scaffold

Participants will receive the MOTIV device

DEVICE

Percutaneous Transluminal Angioplasty (PTA) Device

Participants will receive PTA treatment

Sponsors & Collaborators

  • REVA Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Ehrin Armstrong, MD · Adventist Health

  • Andrej Schmidt, PD Dr. · University Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2025-09-30
Completion
2029-03-31
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406622 on ClinicalTrials.gov