Treatment for erectile dysfunction using a special drug-coated balloon

Feasibility and Safety of Selution SLR™ Sirolimus-eluting Balloon in Patients With Distal Internal Pudendal-penile Artery Disease and Erectile Dysfunction: : PERFECT-SELUTION First-in-man (FIM)

This study is testing a special drug-coated balloon to see if it can help men with erectile dysfunction caused by narrowed arteries feel better compared to a standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 20 Years and up
• Sex: Male
• Sponsor: National Taiwan University Hospital (other)
• Locations: 1 site (Taipei City)
• Trial ID: NCT05362994 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of the Selution SLR™ sirolimus-eluting balloon in treating erectile dysfunction caused by stenosis in the internal pudendal and penile arteries. The study involves a prospective, randomized, single-blinded design with two arms, comparing the new drug-coated balloon to a standard plain balloon angioplasty. Patients will be monitored for improvements in erectile function and restenosis rates over an 8-month period following the procedure. The trial aims to provide insights into the potential benefits of this innovative treatment approach for men suffering from erectile dysfunction related to arterial disease.

Who should consider this trial

Good fit: Ideal candidates are men aged 20 and older with erectile dysfunction and confirmed arterial stenosis in the pelvic region.

Not a fit: Patients with non-vascular causes of erectile dysfunction or severe stenosis in other related arteries may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve erectile function in men with arterial-related erectile dysfunction.

How similar studies have performed: Previous studies have shown promising results with similar angioplasty techniques, indicating potential for success with this new approach.

Eligibility criteria

Inclusion Criteria:

1. Men ≥20 years of age with erectile dysfunction defined as an IIEF-EF score of ≤25 points;
2. Inadequate response to any dosage of phosphodiesterase 5 inhibitor (PDE5i) for more than 6 months before enrollment (either chronic or on-demanding).
3. Hemodynamic conditions stable (systolic BP \> 100 mmHg, heart rate 40-100/min).
4. The anatomical inclusion criteria, based on pelvic CT angiography, are luminal diameter stenosis of ≥50% in the distal internal pudendal and/or penile arteries with proximal reference vessel diameter of ≥1.5 mm and a target-lesion length of ≤40 mm;

Exclusion Criteria:

1. 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;
2. Any non-vascular cause of erectile dysfunction (i.e., pelvic irradiation, pelvic trauma, Peyronie's disease, etc.), which is deemed irreversible by urologist;
3. Untreated hypogonadism (serum total testosterone \<2.5 ng/ml) within 28 days before enrollment;
4. 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;
5. Acute coronary syndrome, stroke, or life-threatening arrhythmia within 3 months before enrollment;
6. Poorly controlled diabetes mellitus with glycosylated hemoglobin levels \>9%;
7. Patient on dialysis or has known renal insufficiency (serum creatinine \> 2.5 mg/dl, or estimated Glomerular Filtration Rate \<30 ml/min/1.732);
8. Serum creatinine levels \>3.0 mg/dl;
9. Bleeding diathesis (like active peptic ulcer, active bleeding, etc.) precluding the use of antiplatelets or anticoagulants or known hypercoagulopathy;
10. Any malignancy or debilitating disease with life expectancy of fewer than 12 months;
11. Known intolerance to contrast agents, aspirin, heparin, all P2Y12 inhibitors, or sirolimus.
12. Severe hepatic insufficiency;

Where this trial is running

Taipei City

• Tzung-Dau Wang — Taipei City, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Tzung-Dau Wang, MD, PhD — National Taiwan University Hospital
• Study coordinator: Tzung-Dau Wang, MD, PhD

Conditions: Erectile Dysfunction, Peripheral Arterial Disease, Arterial Stenosis, angioplasty, drug-coated balloon, erectile dysfunction, pelvic artery disease, peripheral artery disease