Status:
RECRUITING
Selution Sirolimus-eluting Balloon for Internal Pudendal-penile Artery Disease-related Erectile Dysfunction
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
M.A. Med Alliance S.A.
Conditions:
Erectile Dysfunction
Peripheral Arterial Disease
Eligibility:
MALE
20+ years
Phase:
NA
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 ...
Detailed Description
Study Design 1. Prospective, randomized, single-blinded, two-arm, single-center, first-in-man, proof-of-concept trial. 2. Safety and efficacy measures will be monitored and collected by the study phy...
Eligibility Criteria
Inclusion
- 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).
- 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
- 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;
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05362994
Start Date
September 19 2022
End Date
February 28 2025
Last Update
April 30 2024
Active Locations (1)
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1
Tzung-Dau Wang
Taipei, Taiwan, 100225