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

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · May 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for men experiencing erectile dysfunction (ED) related to problems in the blood vessels that supply the pelvic and penile areas. The treatment being tested is the Selution SLR™ sirolimus drug-coated balloon, which is designed to improve blood flow and potentially enhance erectile function. The trial aims to see how effective and safe this new balloon is compared to other treatments, with a focus on reducing the chances of blood vessel narrowing again after the procedure.

To be eligible for this trial, participants must be men aged 20 or older who have difficulty achieving or maintaining an erection, as measured by a specific scoring system. They should also have not responded well to common ED medications for at least six months and have certain blood flow problems in their pelvic arteries. Participants can expect to undergo a procedure where this special balloon is used to open up the narrowed arteries, and they will be monitored for improvements in their erectile function and any side effects. It's important to note that some individuals, such as those with specific medical conditions or unrelated causes of ED, may not qualify for the trial.

Gender

MALE

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;