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NCT06182397 · ClinicalTrials.gov registry record · NA
Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
A NA study of Arterial Disease of Legs and Below-the-knee Obstruction, sponsored by Concept Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 368
- Enrollment target
- 20
- Study locations
NCT06182397 is a NA study of Arterial Disease of Legs and Below-the-knee Obstruction that is actively recruiting participants, run by Concept Medical. The registered enrollment target is 368 participants. The trial reports 20 study locations across 8 states.
The verdict
NCT06182397, a NA study of Arterial Disease of Legs and Below-the-knee Obstruction, is actively recruiting participants, sponsored by Concept Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 368 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx. 50 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Europe, Australia and Asia. Each site will be capped at 30 maximum subjects recruited. The main goal of this clinical trial is to determine the effectiveness and safety of the sirolimus drug coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of below the knee arterial disease. Eligible subjects will be randomised in a 1:1 allocation ratio and stratified by recruiting countries. Each subject will be randomized to receive either: 1. MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or 2. Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA).
Conditions Studied
Interventions
- DEVICE MagicTouch PTA Sirolimus drug coated balloon
- DEVICE Placebo balloon angioplasty
Study Locations (20)
New York
- Northwell Health Long Island Jewish Medical Center - Lake Success
- NYU Langone Medical Center - New York
- The Mount Sinai Hospital - New York
- Columbia University Irving Medical center/NYPH - New York
- New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery - New York
- St. Francis Hospital and Heart Center - Roslyn
- Westchester Medical Center - Valhalla
Florida
- Clearwater Cardiovascular Consultants - Clearwater
- Baptist Hospital of Miami - Miami
- University of South Florida - Tampa
California
- Cedars-Sinai Medical Center - Los Angeles
- University of California Los Angeles - Los Angeles
Iowa
- Vascular Institute of the Midwest - Davenport
- Unity Point Health Des Moines - Des Moines
New Jersey
- Deborah Heart and Lung Center - Browns Mills
- Virtua Healthcare - Virtua Our Lady of Lourdes - Marlton
Ohio
- The Christ Hospital Network Outpatient Center - Cincinnati
- University Hospitals Cleveland Medical Center - Cleveland
Arizona
- Honor Health Research & Innovation Institute - Scottsdale
Michigan
- Atria Vascular and Vein - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2025-01-16 |
| Est. Completion | 2031-02-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06182397
The ClinicalTrials.gov registry entry for NCT06182397 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 368 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Concept Medical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Arterial Disease of Legs appearing as the primary indexed condition, and to 2 interventions - of which MagicTouch PTA Sirolimus drug coated balloon is the first listed.
NCT06182397 reports 20 study locations spanning 8 distinct geographic areas - top geographies include New York, Florida, California.
Frequently Asked Questions
What is clinical trial NCT06182397 about?
NCT06182397 is a clinical study titled "Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease". This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx. 50 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Europe, Australia and Asia. Each site will b...
What is the current status of trial NCT06182397?
This trial is currently recruiting. It is a NA study. The enrollment target is 368 participants. The study started on 2025-01-16. Estimated completion is 2031-02-01.
What conditions does trial NCT06182397 study?
This clinical trial studies the following conditions: Arterial Disease of Legs, Below-the-knee Obstruction, PAD - Peripheral Arterial Disease.
What interventions are being tested in trial NCT06182397?
The interventions under investigation include: MagicTouch PTA Sirolimus drug coated balloon (DEVICE), Placebo balloon angioplasty (DEVICE).
Who is sponsoring clinical trial NCT06182397?
This trial is sponsored by Concept Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06182397 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Iowa, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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