CORONARY

 

Indication

Patient
Numbers

Region

Design

Status

ClinicalTrials.gov
SELUTION FIM*

DeNovo
SV/ISR

56

Asia

Single Arm

Completed
12 mth Data

View Publication

SELUTION4ISR
IDE FDA Trial*

ISR

418

US, Europe, Canada,
Latin America

1:1 RCT
DEB vs SOC**

Enrolling

NCT04280029

SELUTION DeNovo*

DeNovo

3,326

Asia & Europe

1:1 RCT
DEB Strategy vs DES Strategy

Enrolling

NCT04859985

SELUTION 4DeNovo
IDE FDA Trial*

DeNovo

960

US & Europe

1:1 RCT
DEB vs DES

Enrolling

NCT05946629

* Med Alliance Sponsored Trials. M.A. Med Alliance SA is a Cordis company.
** SOC = Standard of Care

PERIPHERAL

 

Indication

Patient
Numbers

Region

Design

Status

ClinicalTrials.gov

SELUTION FIM*

SFA

50

Germany

Single Arm

Completed
24 mth data

NCT02941224

SELUTION4SFA
IDE FDA Trial*

SFA/Popliteal

300

US, Europe 
and Asia

2:1 RCT
DEB vs POBA

Enrolling

NCT05132361

SUCCESS
Post Market Registry*

SFA, Popliteal, 
Tibial and Pedal

723

Asia, Europe and 
Latin America

Single Arm

Enrollment
Completed

NCT04776434

SELUTION4BTK
IDE FDA Trial*

BTK

376

US, Europe 
and Asia

1:1 RCT
DEB vs POBA

Enrolling

NCT05055297

Japan SFA*

SFA

134

Japan

Single arm

Completed
12 mth data

JPICCTI - 205434

PRESTIGE**

BTK

25

Asia

Single arm

Completed
24 mth data

NCT04071782

PRISTINE**

SFA/BTK

75

Asia

Single arm

Completed
12 mth data

NCT04534257

LIMUS FLOW**

SFA

70

Germany

RCT

Completed
1 mth data

NCT05450042

* 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
Completed

NCT04327609

* 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.