Actively Recruiting
Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
Led by Concept Medical Inc. · Updated on 2026-01-02
368
Participants Needed
29
Research Sites
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older, or minimum adulthood age according to local regulations
- Rutherford class 4 with documented WIFI score, not exceeding 30% of participants
- Rutherford class 5 to 6 in the target limb with documented WIFI score
- Single or sequential new or re-stenotic lesions (over 50% narrowing or occlusions) from 2 to 20 cm in below-the-knee arteries
- Lesions located in Tibio-peroneal trunk, Peroneal bifurcation, anterior tibial artery, posterior tibial artery, or peroneal artery
- Maximum of two tibial vessels treated per procedure with documented distal runoff
- Inflow arteries free from severe narrowing (less than 50% stenosis) or successfully treated if previously narrowed
- Target vessel has less than 50% narrowing with good runoff into named tibio-pedal arteries
You will not qualify if you...
- Life expectancy of one year or less due to other medical conditions
- Currently participating in another investigational drug or device study not yet reaching primary endpoint
- Pregnant, lactating, or planning pregnancy during the study
- Extensive tissue loss requiring complex foot reconstruction or non-traditional amputation, including osteomyelitis near metatarsal head, plantar gangrene, large plantar ulcers over 3 cm, full thickness heel ulcers, wounds involving calcaneal bone, neuropathic or non-ischemic wounds, wounds needing flap coverage or complex management, or full thickness dorsal foot wounds with tendon or bone exposure
- Prior bypass surgery of the target vessel
- Planned major amputation of the target limb
- Previously implanted stent in the target lesion
- Vulnerable or protected adults
- Bleeding disorders preventing use of required antiplatelet medications
- Known allergy to sirolimus
- Severe kidney disease with eGFR less than 30
- Failure to cross target lesion with guide wire during procedure
- Lesions extending beyond the ankle joint
- Failure to achieve less than 30% residual stenosis before randomization
- Lesions requiring treatment via retrograde access; treatment must be antegrade
- Use of other drug coated balloons, bare metal stents, drug eluting stents, specialty balloons, or atherectomy devices at target lesions (except non-compliant balloons); approved devices allowed for inflow and non-target lesions
AI-Screening
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Trial Site Locations
Total: 29 locations
1
Honor Health Research & Innovation Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
4
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States, 33756
Actively Recruiting
5
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Actively Recruiting
6
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
7
Vascular Institute of the Midwest
Davenport, Iowa, United States, 52807
Actively Recruiting
8
Unity Point Health Des Moines
Des Moines, Iowa, United States, 50309
Actively Recruiting
9
Atria Vascular and Vein
Farmington Hills, Michigan, United States, 48334
Not Yet Recruiting
10
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
Actively Recruiting
11
Virtua Healthcare - Virtua Our Lady of Lourdes
Marlton, New Jersey, United States, 08053
Actively Recruiting
12
Northwell Health Long Island Jewish Medical Center
Lake Success, New York, United States, 11042
Actively Recruiting
13
NYU Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
14
The Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
15
Columbia University Irving Medical center/NYPH
New York, New York, United States, 10032
Actively Recruiting
16
New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery
New York, New York, United States, 10065
Actively Recruiting
17
St. Francis Hospital and Heart Center
Roslyn, New York, United States, 11576
Not Yet Recruiting
18
Westchester Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
19
The Christ Hospital Network Outpatient Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
20
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
21
Lankenau Institute for Medical Research Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Actively Recruiting
22
University of Pennsylvania - Penn Heart and Vascular Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
23
Medical University of South Carolina(MUSC) Health Ashley River Tower
Charleston, South Carolina, United States, 29425
Actively Recruiting
24
Ascension Seton Medical Center Austin
Austin, Texas, United States, 78705
Actively Recruiting
25
Baylor Research Institute
Dallas, Texas, United States, 75226
Actively Recruiting
26
HOPE Vascular and Podiatry
Houston, Texas, United States, 77054
Actively Recruiting
27
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
28
San Antonio Vascular and Endovascular Clinic
San Antonio, Texas, United States, 78221
Not Yet Recruiting
29
University of Washington Seattle
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
F
Farhana Siddique
CONTACT
D
Dario Gattuso
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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