Drug Eluting Balloon Clinical Research
Cordis is committed to advancing the treatment of cardiovascular and peripheral artery disease and improving the lives of patients around the world.
CORONARY
Indication | Patient | Region | Design | Status | ClinicalTrials.gov | |
---|---|---|---|---|---|---|
SELUTION FIM* | DeNovo | 56 | Asia | Single Arm | Completed | |
SELUTION4ISR IDE FDA Trial* | ISR | 418 | US, Europe, Canada, | 1:1 RCT DEB vs SOC** | Enrollment | |
SELUTION DeNovo* | DeNovo | 3,326 | Asia & Europe | 1:1 RCT DEB Strategy vs DES Strategy | Enrollment | |
SELUTION 4DeNovo IDE FDA Trial* | DeNovo | 960 | US & Europe | 1:1 RCT DEB vs DES | Enrolling |
* Med Alliance Sponsored Trials. M.A. Med Alliance SA is a Cordis company.
** SOC = Standard of Care
PERIPHERAL
Indication | Patient | Region | Design | Status | ClinicalTrials.gov | |
---|---|---|---|---|---|---|
SELUTION FIM* | SFA | 50 | Germany | Single Arm | Completed | |
SELUTION4SFA IDE FDA Trial* | SFA/Popliteal | 300 | US, Europe | 2:1 RCT DEB vs POBA | Enrolling | |
SUCCESS Post Market Registry* | SFA, Popliteal, | 723 | Asia, Europe and | Single Arm | Enrollment | |
SELUTION4BTK IDE FDA Trial* | BTK | 376 | US, Europe | 1:1 RCT DEB vs POBA | Enrolling | |
Japan SFA* | SFA | 134 | Japan | Single arm | Completed | |
PRESTIGE** | BTK | 25 | Asia | Single arm | Completed | |
PRISTINE** | SFA/BTK | 75 | Asia | Single arm | Completed | |
LIMUS FLOW** | SFA | 70 | Germany | RCT | Completed |
* Med Alliance Sponsored Trials. M.A. Med Alliance SA is a Cordis company.
** Physician Initiated Trials
OTHER
Indication | Patient Numbers | Region | Design | Status | ClinicalTrials.gov | |
---|---|---|---|---|---|---|
SAVE* | AVF** | 84 | Asia, Europe | 1:1 RCT DEB vs POBA | Enrollment |
* Med Alliance Sponsored Trials. M.A. Med Alliance SA is a Cordis company.
** SELUTION SLR DEB is not currently approved for Arteriovenous Fistula (AVF) indications in Europe nor the United States.