Condition: Coronary Artery Disease · Sponsor: M.A. Med Alliance S.A.
Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.
This description comes directly from the study's public registry record.
Rebecca Apruzzese · 2016001527 · rebecca.apruzzese@cordis.com
Susanne Meis · +491718918919 · susanne.meis@cordis.com
Always discuss trial participation with your own doctor first.
| St. Bernards | Jonesboro, Arkansas, United States | Recruiting |
| CISD Sharp Chula Vista | Chula Vista, California, United States | Recruiting |
| Cedars Sinai | Los Angeles, California, United States | Recruiting |
| HCA Los Robles | Thousand Oaks, California, United States | Recruiting |
| Harbor UCLA | Torrance, California, United States | Recruiting |
| Colorado Heart and Vascular | Golden, Colorado, United States | Recruiting |
| ClinRe | Thornton, Colorado, United States | Recruiting |
| Yale New Haven Hospital | New Haven, Connecticut, United States | Recruiting |
| MedStar Washington Hospital Center | Washington D.C., District of Columbia, United States | Recruiting |
| HCA Florida JFK | Atlantis, Florida, United States | Withdrawn |
| Manatee Memorial | Bradenton, Florida, United States | Recruiting |
| Mease Countryside Hospital | Clearwater, Florida, United States | Recruiting |
+ 58 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05946629