Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

ClinicalTrials.gov ID: NCT06182397

Public ClinicalTrials.gov record NCT06182397. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

MAGICAL BTK: Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT06182397
Recruitment status: Recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Concept Medical Inc.; Industry
Enrollment: 368 participants

Conditions and interventions

Conditions

Interventions

MagicTouch PTA Sirolimus drug coated balloon Device
Placebo balloon angioplasty Device

Device

Eligibility (public fields only)

Age range: 21 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 15, 2025
Primary completion: Nov 30, 2026
Completion: Jan 31, 2031
Last update posted: Jan 1, 2026

2025 – 2031

United States locations

U.S. sites: 29
U.S. states: 12
U.S. cities: 25

Facility	City	State	ZIP	Site status
Honor Health Research & Innovation Institute	Scottsdale	Arizona	85258	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	90048	Recruiting
University of California Los Angeles	Los Angeles	California	90095	Not yet recruiting
Clearwater Cardiovascular Consultants	Clearwater	Florida	33756	Recruiting
Baptist Hospital of Miami	Miami	Florida	33176	Recruiting
University of South Florida	Tampa	Florida	33606	Recruiting
Vascular Institute of the Midwest	Davenport	Iowa	52807	Recruiting
Unity Point Health Des Moines	Des Moines	Iowa	50309	Recruiting
Atria Vascular and Vein	Farmington Hills	Michigan	48334	Not yet recruiting
Deborah Heart and Lung Center	Browns Mills	New Jersey	08015	Recruiting
Virtua Healthcare - Virtua Our Lady of Lourdes	Marlton	New Jersey	08053	Recruiting
Northwell Health Long Island Jewish Medical Center	Lake Success	New York	11042	Recruiting
NYU Langone Medical Center	New York	New York	10016	Recruiting
The Mount Sinai Hospital	New York	New York	10029	Recruiting
Columbia University Irving Medical center/NYPH	New York	New York	10032	Recruiting
New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery	New York	New York	10065	Recruiting
St. Francis Hospital and Heart Center	Roslyn	New York	11576	Not yet recruiting
Westchester Medical Center	Valhalla	New York	10595	Recruiting
The Christ Hospital Network Outpatient Center	Cincinnati	Ohio	45219	Recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	44106	Recruiting
Lankenau Institute for Medical Research Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	19010	Recruiting
University of Pennsylvania - Penn Heart and Vascular Center	Philadelphia	Pennsylvania	19104	Recruiting
Medical University of South Carolina(MUSC) Health Ashley River Tower	Charleston	South Carolina	29425	Recruiting
Ascension Seton Medical Center Austin	Austin	Texas	78705	Recruiting
Baylor Research Institute	Dallas	Texas	75226	Recruiting
HOPE Vascular and Podiatry	Houston	Texas	77054	Recruiting
The Heart Hospital Baylor Plano	Plano	Texas	75093	Recruiting
San Antonio Vascular and Endovascular Clinic	San Antonio	Texas	78221	Not yet recruiting
University of Washington Seattle	Seattle	Washington	98104	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06182397, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 1, 2026 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06182397 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →