
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 |
Presented Results |
|
---|---|---|---|---|---|---|---|
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 |
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 |
|
* 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.