NCT05406622

MOTIV BTK Randomized Controlled Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: REVA Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Critical Limb Ischemia

Interventions

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

Timeline

• Start date: 2022-06-10
• Primary completion: 2025-09-30
• Completion: 2029-03-31
• First posted: 2022-06-06
• Last updated: 2025-04-02

Locations

4 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study