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

Summary

According to epidemiological surveys in various countries around the world, the prevalence of erectile dysfunction in men over the age of 40 is about 40%. Previous angiography studies have shown that nearly 70% of erectile dysfunction patients do have pelvic arterial stenosis. Our team leads the world in the use of percutaneous angioplasty combined with drug-eluting stents or paclitaxel-coated balloons to delineate the stenosis of the pelvic pudendal artery and penile artery The successful report of erectile dysfunction shows that the 12-month erectile function improvement rate is nearly 60%, and the vascular restenosis rate is also about 40% to 50%, obviously there is room for improvement. This study aims to observe the clinical efficacy, safety and lower restenosis rate of the newly developed "Selution SLR™ sirolimus drug sustained-release coated balloon" in patients with distal internal pudendal artery and penile artery stenosis complicated with erectile dysfunction . Compared with drug-eluting stents and paclitaxel drug-coated balloons, the Sirolimus drug-coated balloon has two advantages: one is that the clinical performance of sirolimus is much better than that of paclitaxel when used in drug-eluting stents; the other is that there is no indwelling stent in the Therefore, it can reduce the local stimulation of blood vessels and maintain the biological activity of blood vessels. Selution SLR™ sirolimus drug sustained-release coated balloon has obtained European Union approval for marketing, and has also been granted four Breakthrough Device Designation Status by the U.S. Food and Drug Administration (FDA): coronary artery disease, coronary artery disease In-stent restenosis, infra-knee artery disease, and arteriovenous canals.

Conditions

• Erectile Dysfunction
• Peripheral Arterial Disease
• Arterial 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.

Sponsors & Collaborators

• M.A. Med Alliance S.A.

  collaborator INDUSTRY

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Tzung-Dau Wang, MD, PhD · National Taiwan University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-19

Primary Completion

2025-02-28

Completion

2025-02-28

Countries

• Taiwan

Study Locations