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Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease

NCT06071429 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

  • Chronic Limb-Threatening Ischemia

Interventions

DEVICE

MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold

CLTI patients treated with MAGNITUDE BRS

DEVICE

Percutaneous Transluminal Angioplasty (PTA)

CLTI patients treated with PTA

Sponsors & Collaborators

  • R3 Vascular Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Secemsky, MD · Beth Israel Deaconess Medical Center

  • Marianne Brodmann, MD · Medical University of Graz

  • Ramon L Varcoe, MD · Prince of Wales Private Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2028-03-01
Completion
2032-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06071429 on ClinicalTrials.gov