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

NCT05362994 | Unknown

• 1 other identifier: 202105008DIPB
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

angioplasty; drug-coated balloon; erectile dysfunction; pelvic artery disease; peripheral artery disease; pudendal artery; penile artery

Outcome Measures

Primary Outcomes (2)

• Primary efficacy endpoint

  CT angiographic binary restenosis (≥50% lumen diameter stenosis) at 12 weeks follow-up.

  12 weeks

• Primary safety endpoint

  The rate of major adverse events at 12 weeks after intervention, defined as procedure-related death, occurrence of perineal hematoma, gangrene or necrosis (glans penis, penile shaft, scrotal, or anal), or the need for subsequent perineal, penile, or anal surgery (including target-lesion or vessel revascularization or arterial embolization procedures).

  12 weeks

Study Arms (2)

Plain old balloon (POB) arm

ACTIVE COMPARATOR

Balloon catheter used in the POB arm will be the "Medtronic" Euphora Rapid Exchange Balloon Dilatation Catheter, with diameters from 1.5 mm to 4.0 mm, and length from 6 to 30 mm,

Device: Plain old balloon angioplasty

Drug-eluting balloon (DEB) arm

EXPERIMENTAL

The Selution SLR™ sirolimus-eluting balloon catheter system comprises of a semi-compliant polyamide balloon catheter with low tip profile coated with sirolimus drug (concentration: 1.00 μg/mm2 of balloon surface). Selution sustained limus release (SLR™) sirolimus-eluting balloon provides controlled and 90-day sustained release of sirolimus given its MicroReservoir technology made from biodegradable polymer intermixed with sirolimus. The balloon platform is the percutaneous transluminal coronary angioplasty (PTCA) rapid exchange catheter, with diameters from 2.0 to 4.5 mm and length from 15 to 30 mm.

Device: Selution SLR™ sirolimus-eluting balloon

Interventions

Selution SLR™ sirolimus-eluting balloon DEVICE

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.

Drug-eluting balloon (DEB) arm

Plain old balloon angioplasty DEVICE

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.

Also known as: "Medtronic" Euphora Rapid Exchange Balloon Dilatation Catheter

Plain old balloon (POB) arm

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men ≥20 years of age with erectile dysfunction defined as an IIEF-EF score of ≤25 points;
• Inadequate response to any dosage of phosphodiesterase 5 inhibitor (PDE5i) for more than 6 months before enrollment (either chronic or on-demanding).
• Hemodynamic conditions stable (systolic BP \> 100 mmHg, heart rate 40-100/min).

You may not qualify if:

• The presence of diameter stenosis of ≥70% in the ipsilateral internal iliac artery, anterior division of internal iliac artery, and/or proximal internal pudendal artery, which could not be successfully treated by angioplasty and stenting;
• Any non-vascular cause of erectile dysfunction (i.e., pelvic irradiation, pelvic trauma, Peyronie's disease, etc.), which is deemed irreversible by urologist;
• Untreated hypogonadism (serum total testosterone \<2.5 ng/ml) within 28 days before enrollment;
• Isolated penile veno-occlusive dysfunction (venous leak) by duplex ultrasonography with right or left cavernosal artery end-diastolic velocity \>10 cm/s, peak systolic velocity \>40 cm/s, and resistance index (RI) \<0.75;
• Acute coronary syndrome, stroke, or life-threatening arrhythmia within 3 months before enrollment;
• Poorly controlled diabetes mellitus with glycosylated hemoglobin levels \>9%;
• Patient on dialysis or has known renal insufficiency (serum creatinine \> 2.5 mg/dl, or estimated Glomerular Filtration Rate \<30 ml/min/1.732);
• Serum creatinine levels \>3.0 mg/dl;
• Bleeding diathesis (like active peptic ulcer, active bleeding, etc.) precluding the use of antiplatelets or anticoagulants or known hypercoagulopathy;
• Any malignancy or debilitating disease with life expectancy of fewer than 12 months;
• Known intolerance to contrast agents, aspirin, heparin, all P2Y12 inhibitors, or sirolimus.
• Severe hepatic insufficiency;

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• M.A. Med Alliance S.A.: collaborator

Study Sites (1)

Tzung-Dau Wang

Taipei, 100225, Taiwan

RECRUITING

Related Publications (4)

• Wang TD, Lee CK, Chia YC, Tsoi K, Buranakitjaroen P, Chen CH, Cheng HM, Tay JC, Teo BW, Turana Y, Sogunuru GP, Wang JG, Kario K; HOPE Asia Network. Hypertension and erectile dysfunction: The role of endovascular therapy in Asia. J Clin Hypertens (Greenwich). 2021 Mar;23(3):481-488. doi: 10.1111/jch.14123. Epub 2020 Dec 14.

  PMID: 33314715 RESULT

• Wang TD, Lee WJ, Yang SC, Lin PC, Tai HC, Liu SP, Huang CH, Chen WJ, Chen MF, Hsieh JT. Clinical and Imaging Outcomes up to 1 Year Following Balloon Angioplasty for Isolated Penile Artery Stenoses in Patients With Erectile Dysfunction: The PERFECT-2 Study. J Endovasc Ther. 2016 Dec;23(6):867-877. doi: 10.1177/1526602816669337. Epub 2016 Sep 14.

  PMID: 27629440 RESULT

• Wang TD, Lee WJ, Yang SC, Lin PC, Tai HC, Hsieh JT, Liu SP, Huang CH, Chen WJ, Chen MF. Safety and six-month durability of angioplasty for isolated penile artery stenoses in patients with erectile dysfunction: a first-in-man study. EuroIntervention. 2014 May;10(1):147-56. doi: 10.4244/EIJV10I1A23.

  PMID: 24832642 RESULT

• Wang TD. Commentary: Angioplasty of Internal Pudendal and Penile Arteries for Arteriogenic Erectile Dysfunction: Reassuring, but the Jury Is Still Out. J Endovasc Ther. 2018 Dec;25(6):716-718. doi: 10.1177/1526602818807774. Epub 2018 Oct 22. No abstract available.

  PMID: 30343618 RESULT

MeSH Terms

Conditions

Erectile Dysfunction; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Tzung-Dau Wang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzung-Dau Wang, MD, PhD

CONTACT

+886-2-23123456; tdwang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be masked about which treatment strategy will be executed. Randomization will be done after diagnostic invasive pelvic angiography. The intervention procedure between both randomization groups is comparable, thus unmasking is difficult.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will take place before angioplasty. Patients will be randomized to either the plain old balloon (POB) group or the drug-eluting balloon (DEB) group. 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. While in the drug-eluting balloon (DEB) group, 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.

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: September 19, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)