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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06071429
The ClinicalTrials.gov registry entry for NCT06071429 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 151-participant average among 9 other Chronic Limb-Threatening Ischemia trials with a reported enrollment target (99% higher). The listed sponsor is R3 Vascular, which has 1 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.