Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease

Recruiting now · Not applicable

Conditions studied: Chronic Limb-Threatening Ischemia

In brief

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.

Key facts

Study ID
NCT06071429
Run by
R3 Vascular Inc.
People needed
300
Starts
2025-04-11
Expected to finish
2032-03-01
Last updated by the study team
2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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