Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease

Not Applicable

Not yet recruiting

• Conditions: Chronic Limb-Threatening Ischemia
• Interventions: Device: MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold; Device: Percutaneous Transluminal Angioplasty (PTA)

• Registration Number: NCT06071429
• Lead Sponsor: R3 Vascular Inc.

Brief Summary

The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Approximately 276 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at up to 60 clinical sites globally.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-06
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07
• Primary Completion: 2028-03-01
• Study Completion: 2032-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAGNITUDE BRS	MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold	Participants who receive the MAGNITUDE BRS device will be included in this arm
Percutaneous Transluminal Angioplasty (PTA)	Percutaneous Transluminal Angioplasty (PTA)	Participants who receive a PTA device will be included in this arm

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency	6 months	Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR).
Primary Safety Endpoint: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death)	POD at 30 Days and MALE at 6 months	Major Adverse Limb Event (MALE) includes above ankle amputation in index limb, major re-intervention on index limb at 6 months and POD includes perioperative (30-day) mortality.

Trial Locations

Locations (1)

CUMC/NYP; 🇺🇸 New York, New York, United States