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:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT02178761
Eligibility Criteria:
Inclusion Criteria:
* men 20 years of age or older with "consistent" erectile dysfunction defined as both IIEF-5 scores, taken at least 4 weeks apart, are in the range of 5 to 21 points and with a difference of \<=2 points
* the anatomical inclusion criteria, based on pelvic CT angiography, are unilateral luminal diameter stenosis \>=70% or bilateral diameter stenoses \>=50% in the pelvic arteries with reference vessel diameter \>=2.5 mm and \<=4.0 mm and a target-lesion length \<=40 mm
Exclusion Criteria:
* the arterial inflow to the penis is entirely from the accessory pudendal arteries rather than the usual internal pudendal artery and common penile artery;
* the presence of focal diameter stenosis \>=70% in the common iliac artery, internal iliac artery, or anterior division of internal iliac artery;
* previous radical prostatectomy, pelvic radiation, or Peyronie's disease;
* untreated hypogonadism (serum total testosterone \<300 ng/dL within 14 days before enrollment);
* acute coronary syndrome, stroke, or life-threatening arrhythmia within 3 months before enrollment;
* poorly controlled diabetes mellitus with glycosylated hemoglobin levels \>9%;
* serum creatinine levels \>2.5 mg/dL;
* bleeding diathesis or known hypercoagulopathy;
* life expectancy of fewer than 12 months;
* known intolerance to contrast agents
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT02178761
Study Brief:
Protocol Section:
NCT02178761