Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study (NCT01341483) | Clinical Trial Compass
TerminatedNot Applicable
Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study
Stopped: Sufficient information gathered
United States19 participantsStarted 2011-04
Plain-language summary
The purpose of this study is to determine the proportion of men with known or suspected coronary artery disease (CAD) and/or peripheral arterial disease (PAD) that have angiographic identifiable erectile related artery (ERA) atherosclerotic disease defined as at least one ERA stenosis greater than or equal to 50% (per core lab Quantitative Vascular Analysis - QVA).
Who can participate
Age range35 Years – 70 Years
SexMALE
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Inclusion Criteria:
* Subject must be undergoing coronary or peripheral angiography for suspected or known coronary or peripheral atherosclerotic disease
* Subject must be male ≥ 35 and ≤ 70 years old
* Subject must provide written informed consent before any study-related procedures are performed
* Subject must agree to comply with study procedures and follow-up for the entire length of the study
Exclusion Criteria:
* Subject is unable to safely attempt sexual intercourse secondary to severe cardiac disease or other health condition
* Subject has a life expectancy of \< 12 months
* Subject's serum creatinine is \> 2.5 mg/dl
* Subject has known aorto-iliac occlusive disease, previous AAA endograft procedure or open surgical procedure
* Subject has history of prostatic carcinoma requiring surgery (i.e., prostatectomy), pelvic radiation, or hormonal/chemotherapy
* Subject has a history of myocardial infarction, stroke, life-threatening arrhythmia, or unstable angina requiring hospitalization within 3 months (90 days) prior to enrollment
* Subject has had exposure to PDE5 inhibitor (per subject's concomitant medication list) within the 72 hours prior to the scheduled baseline angiography
* Subject has a history of renal transplantation
* Subject has a penile implant
* Subject has become unstable or has received a maximum radiation dose, increased procedure time, and/or maximum contrast dose (in the Investigator's opinion) from the primary angiographic procedure that would com…
What they're measuring
1
To determine the proportion of men with known or suspected CAD and/or PAD that have angiographic identifiable erectile related artery (ERA) atherosclerotic disease