Condition: Arterial Disease of Legs · Below-the-knee Obstruction · PAD - Peripheral Arterial Disease · Sponsor: Concept Medical Inc.
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).
This description comes directly from the study's public registry record.
Farhana Siddique · +919725495366 · farhana@conceptmedical.com
Dario Gattuso · +393292467132 · dario@conceptmedical.com
Always discuss trial participation with your own doctor first.
| Honor Health Research & Innovation Institute | Scottsdale, Arizona, United States | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | Recruiting |
| University of California Los Angeles | Los Angeles, California, United States | Not Yet Recruiting |
| Clearwater Cardiovascular Consultants | Clearwater, Florida, United States | Recruiting |
| Baptist Hospital of Miami | Miami, Florida, United States | Recruiting |
| University of South Florida | Tampa, Florida, United States | Recruiting |
| Vascular Institute of the Midwest | Davenport, Iowa, United States | Recruiting |
| Unity Point Health Des Moines | Des Moines, Iowa, United States | Recruiting |
| Atria Vascular and Vein | Farmington Hills, Michigan, United States | Not Yet Recruiting |
| Deborah Heart and Lung Center | Browns Mills, New Jersey, United States | Recruiting |
| Virtua Healthcare - Virtua Our Lady of Lourdes | Marlton, New Jersey, United States | Recruiting |
| Northwell Health Long Island Jewish Medical Center | Lake Success, New York, United States | Recruiting |
+ 17 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06182397