Trials / Recruiting
RecruitingNCT06071429
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- R3 Vascular Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold | CLTI patients treated with MAGNITUDE BRS |
| DEVICE | Percutaneous Transluminal Angioplasty (PTA) | CLTI patients treated with PTA |
Timeline
- Start date
- 2025-04-11
- Primary completion
- 2028-03-01
- Completion
- 2032-03-01
- First posted
- 2023-10-06
- Last updated
- 2026-02-06
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06071429. Inclusion in this directory is not an endorsement.