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 | Presented Results | |
|---|---|---|---|---|---|---|---|
| SELUTION FIM* | DeNovo | 56 | Asia | Single Arm | Completed |
| |
| SELUTION4ISR IDE FDA Trial* | ISR | 418 | US, Europe, Canada, | 1:1 RCT DEB vs SOC** | Completed | ||
| SELUTION DeNovo* | DeNovo | 3,326 | Asia & Europe | 1:1 RCT DEB Strategy vs DES Strategy | Completed | ||
| SELUTION 4DeNovo IDE FDA Trial* | DeNovo | 960 | US & Europe | 1:1 RCT DEB vs DES | Enrolling |
| |
| Japan Coronary Study (S2024-01)* | DeNovo & ISR | DeNovo - 150 | Japan | DeNovo - 2:1 RCT (SELUTION SLR DEB vs Paclitaxel DCB) ISR - Single Arm | Enrolling | jRCT2032250301 |
|
* 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 | Presented Results | |
|---|---|---|---|---|---|---|---|
| SELUTION FIM* | SFA | 50 | Germany | Single Arm | Completed |
| |
| SELUTION4SFA IDE FDA Trial* | SFA/Popliteal | 300 | US, Europe | 2:1 RCT SELUTION SLR DEB vs PTA | Enrollment |
| |
| SUCCESS Post Market Registry* | SFA, Popliteal, | 723 | Asia, Europe and | Single Arm | Completed | ||
| 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 |
| |
| SELUTION SFA Italy** | SFA | 80 | Italy | Single arm | Completed | Long‐Term Efficacy and Safety |
* 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.