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NCT06071429 · ClinicalTrials.gov registry record · NA
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
A NA study of Chronic Limb-Threatening Ischemia, sponsored by R3 Vascular.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 3
- Study locations
NCT06071429: Recruiting NA study of Chronic Limb-Threatening Ischemia, sponsored by R3 Vascular.
NCT06071429 is a NA study of Chronic Limb-Threatening Ischemia that is actively recruiting participants, run by R3 Vascular. The registered enrollment target is 300 participants, above the 151-participant average among 9 other Chronic Limb-Threatening Ischemia trials with a reported enrollment target (99% higher). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06071429, a NA study of Chronic Limb-Threatening Ischemia, is actively recruiting participants, sponsored by R3 Vascular.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Major Adverse Limb Event (MALE) includes above ankle amputation in index limb, major re-intervention on index limb at 6 months and POD includes perioperative (30-day) mortality.
Conditions Studied
Interventions
- DEVICE MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold
- DEVICE Percutaneous Transluminal Angioplasty (PTA)
Study Locations (3)
New York
- NYU Langone Health - New York
- CUMC/NYP - New York
- Staten Island University Hospital - Northwell Health - Staten Island
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-04-11 |
| Est. Completion | 2032-03-01 |
| Phase | NA |
What NCT06071429 shows while recruiting
NCT06071429 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 151-participant average among 9 other Chronic Limb-Threatening Ischemia trials with a reported enrollment target (99% higher).
The record links to 1 condition, with Chronic Limb-Threatening Ischemia appearing as the primary indexed condition, and to 2 interventions - of which MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold is the first listed.
NCT06071429 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06071429 about?
NCT06071429 is a clinical study titled "Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease". 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 wil...
What is the current status of trial NCT06071429?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2025-04-11. Estimated completion is 2032-03-01.
What conditions does trial NCT06071429 study?
This clinical trial studies the following conditions: Chronic Limb-Threatening Ischemia.
What interventions are being tested in trial NCT06071429?
The interventions under investigation include: MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold (DEVICE), Percutaneous Transluminal Angioplasty (PTA) (DEVICE).
Who is sponsoring clinical trial NCT06071429?
This trial is sponsored by R3 Vascular, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06071429 being conducted?
This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Limb-Threatening Ischemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06071429's enrollment target sits among peer trials
300 2nd of 9 the highest of 9 other Chronic Limb-Threatening Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Limb-Threatening Ischemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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