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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: Recruiting NA study of Arterial Disease of Legs and Below-the-knee Obstruction, sponsored by Concept Medical.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Binary restenosis will be defined as the proportion of subjects with duplex ultrasonography-derived peak systolic velocity ratio of \> 2.0 with correlating factors. If the PSV at the reference area in the vessel is abnormal, the core laboratory will employ the following other criteria to diagnose a stenosis of \> 50%: * Monophasic/ low resistive waveforms (parvus tardus) at the stenotic area or distal to an acoustic shadow * Post-stenotic turbulence distal to the stenosis, along with a decrease
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 |
What NCT06182397 shows while recruiting
NCT06182397 is an interventional study that assigns participants to a tested intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06182397's enrollment target sits among peer trials
368 283rd of 2000 higher than 1,717 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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