Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05362994
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;
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT05362994
Study Brief:
Protocol Section:
NCT05362994