Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease

Part of paid clinical trials in New York, New York.

Sponsor
R3 Vascular Inc.
Study ID
NCT06071429
Status
Recruiting
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Conditions

  • Chronic Limb-Threatening Ischemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold — DEVICE
    CLTI patients treated with MAGNITUDE BRS
  • Percutaneous Transluminal Angioplasty (PTA) — DEVICE
    CLTI patients treated with PTA

Study Details

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 Dates

Start date
Apr 11, 2025
Status verified
Feb 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2032

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MAGNITUDE BRS
    Participants who receive the MAGNITUDE BRS device will be included in this arm
  • Active Comparator: Percutaneous Transluminal Angioplasty (PTA)
    Participants who receive a PTA device will be included in this arm

Primary Outcome Measure

Primary Safety Endpoint: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: POD at 30 Days and MALE at 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
CUMC/NYPNew YorkNew York10032
Treena Williams, MS
[email protected]
1(212)342-3485
Sahil A. Parikh, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Natalie Massenburg
[email protected]
(646) 634-6178
Anvar Babaev, M.D. (PRINCIPAL_INVESTIGATOR)
Staten Island University Hospital - Northwell HealthStaten IslandNew York10305
Brandon Dilluvio
[email protected]
(718)226-1997
Mitchell Weinberg, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
CUMC/NYP· New York, NYNYU Langone Health· New York, NYStaten Island University Hospital - Northwell Health· Staten Island, NY

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