Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study
Stopped early
Conditions studied: Erectile Dysfunction Due to Arterial Insufficiency
In brief
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).
Key facts
- Study ID
- NCT01341483
- Run by
- Medtronic Endovascular
- People needed
- 19
- Starts
- 2011-04-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2016-02-01
Who can join
Age: 35 and older, up to 70. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 compromise the safety of the subject by proceeding with enrollment into the IMPASSE study
Where it is running
- Prairie Edication and Research Cooperative — Springfield, Illinois, United States
Full record on ClinicalTrials.gov
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