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Study identifier: NCT06071429 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease

Condition: Chronic Limb-Threatening Ischemia  ·  Sponsor: R3 Vascular Inc.

PhaseNA
Planned participants300
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Megan Hill, B.S.  ·  1(904)540-3844  ·  mhill@r3vascular.com

Josh Smale  ·  1(480)244-9523‬  ·  jsmale@r3vascular.com

Always discuss trial participation with your own doctor first.

Locations (3)

NYU Langone HealthNew York, New York, United StatesRecruiting
CUMC/NYPNew York, New York, United StatesRecruiting
Staten Island University Hospital - Northwell HealthStaten Island, New York, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06071429