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 DeNovo* | DeNovo | 3,323 | Asia & Europe | 1:1 RCT | Completed | ||
| SELUTION4ISR IDE FDA Trial* | ISR | 418 | US, Europe, Canada, | 1:1 RCT | Completed | ||
| SELUTION 4DeNovo IDE FDA Trial* | DeNovo | 960 | US & Europe | 1:1 RCT | Enrolling |
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| SELUTION FIM* | DeNovo | 56 | Asia | Single Arm | Completed | ||
| Japan Coronary Study (S2024-01)* | DeNovo & ISR | DeNovo - 150 | Japan | DeNovo - 2:1 RCT (SELUTION SLR DEB vs Paclitaxel DCB) | Enrolling |
* Med Alliance Sponsored Trials. M.A. Med Alliance SA is a Cordis company.
** SOC = Standard of Care
SELUTION4ISR Trial: Sirolimus-Eluting Balloon vs Repeat Drug-Eluting Stent or Balloon Angioplasty for Coronary In-Stent Restenosis | JACC
SELUTION DeNovo Trial - Primary Endpoint: Sirolimus-Eluting Balloon With Provisional Stenting Versus Systematic Drug-Eluting Stent Implantation to Treat De Novo Coronary Lesions: A Randomized, Open-Label, Noninferiority Trial | Circulation
SELUTION DeNovo Trial - HBR Subgroup: Percutaneous coronary intervention using sirolimus-eluting balloons in patients at high bleeding risk: the SELUTION DeNovo HBR substudy | EuroIntervention
SELUTION FIM Study: Sirolimus-Coated Balloon With a Microsphere-Based Technology for the Treatment of De Novo or Restenotic Coronary Lesions
PERIPHERAL
Indication | Patient | Region | Design | Status | ClinicalTrials.gov | Presented Results | |
|---|---|---|---|---|---|---|---|
| SELUTION4SFA IDE FDA Trial* | SFA/POP | 300 | US, Europe | 2:1 RCT | Completed | ||
| SUCCESS Post Market Registry* | SFA, Popliteal, | 723 | Asia, Europe and | Single arm | Completed | ||
| Japan SFA* | SFA | 134 | Japan | Single arm | Completed | ||
| SELUTION4BTK IDE FDA Trial* | BTK | 376 | US, Europe | 1:1 RCT | Enrolling |
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| SELUTION FIM* | SFA | 50 | Germany | Single Arm | Completed |
| |
| PRESTIGE** | BTK | 25 | Singapore | Single arm | Completed |
| |
| PRISTINE** | SFA/BTK | 75 | Singapore | Single arm | Completed |
| |
| PRELUDE** | SFA/BTK | 158 | Singapore | Single arm | Completed | ||
| LIMUS FLOW** | SFA | 70 | Germany | RCT | Completed |
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| 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
JAPAN SFA: 3-Year Results Following Femoropopliteal Lesion Treatment With a Novel Sirolimus-Eluting Balloon | JACC: Cardiovascular Interventions (2025)
Japan SFA: A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial | JACC: Cardiovascular Interventions (2024)
SELUTION FIM: Six-Month Outcomes From the First-in-Human, Single-Arm SELUTION Sustained-Limus-Release Drug-Eluting Balloon Trial in Femoropopliteal Lesions | J Endvasc Ther (2020)
LIMUS FLOW: Sirolimus Versus Paclitaxel Drug‐Coated Ballons for Femoropopliteal Disease: The LIMUS FLOW Trial (2026)
SELUTION SFA Italy: Long-Term Efficacy and Safety of Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: 3-Year Outcomes | Catheter Cardiovasc Interv (2025)
SELUTION SFA Italy: Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry | J Endovasc Ther (2023)
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.