Selution Sirolimus-eluting Balloon for Internal Pudendal-penile Artery Disease-related Erectile Dysfunction

NARecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

September 19, 2022

Primary Completion Date

February 28, 2025

Study Completion Date

February 28, 2025

Conditions
Erectile DysfunctionPeripheral Arterial DiseaseArterial Stenosis
Interventions
DEVICE

Selution SLR™ sirolimus-eluting balloon

If the residual stenosis is ≤30% after initial plain old balloon angioplasty, the investigators will perform angioplasty with the Selution SLR catheter, inflated at nominal pressure for at least 120 seconds. After dilatation of the entire target-lesion, biplane angiograms and IVUS imaging will be obtained. Technical success is defined as residual diameter stenosis ≤30% and adequate distal run-off. Bail-out stenting will be performed if residual stenosis is \>30%, either after plain old balloon angioplasty or angioplasty with Selution SLR. For lesions with residual stenosis \>30% but not suitable for stenting, repeat angioplasty will be performed for at most twice.

DEVICE

Plain old balloon angioplasty

The investigators routinely start with a balloon catheter with a diameter ≥0.5 mm smaller than the reference vessel and ended with a balloon catheter with the size approximately equal to the reference vessel diameter. Three minutes after balloon predilation, the investigators will obtain an angiogram. If the residual stenosis is ≤30%, no further intervention will be performed in the plain old balloon (POB) group.

Trial Locations (1)

100225

RECRUITING

Tzung-Dau Wang, Taipei

All Listed Sponsors
collaborator

M.A. Med Alliance S.A.

INDUSTRY

lead

National Taiwan University Hospital

OTHER