MedPath

Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease

Not Applicable
Recruiting
Conditions
Chronic Limb-Threatening Ischemia
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

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency6 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

NYU Langone Health

🇺🇸

New York, New York, United States

CUMC/NYP

🇺🇸

New York, New York, United States

NYU Langone Health
🇺🇸New York, New York, United States
Natalie Massenburg
Contact
(646) 634-6178
natalie.massenburg@nyulangone.org
Anvar Babaev, M.D.
Principal Investigator

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