Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study (IMPASSE)
Erectile Dysfunction Due to Arterial Insufficiency
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study|
- To determine the proportion of men with known or suspected CAD and/or PAD that have angiographic identifiable erectile related artery (ERA) atherosclerotic disease [ Time Frame: Baseline through Discharge ] [ Designated as safety issue: No ]Identifiable ERA disease is defined as at least one ERA stenosis greater than or equal to 50 percent (per core lab Quantitative Vascular Analysis - QVA)
- Procedural Safety [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Defined as major adverse event (MAE) rate at 30 days characterized as: 1) Procedure related death (directly related to the ERA DSA portion of the baseline angiography) 2) Occurrence of perineal gangrene or necrosis (penile glans, penile shaft, scrotal or anal) 3) Perineal, penile or anal surgery (including ERA embolization procedures) 4) Renal failure
- To determine the proportion of men with atherosclerotic ERA disease who have erectile dysfunction (ED) through 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]ED is defined as a urological assessment survey (UAS) of less than or equal to 21
- To determine the proportion of men who have atherosclerotic ERA disease and are asymptomatic (i.e., normal erectile function) through 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]Normal erectile function is defined as a UAS score greater than 21
- To determine the proportion of men who have ED without evidence of atherosclerotic ERA disease through 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- The predictive capacity of ERA atherosclerosis for potential future cardiovascular events* including ED in men with baseline normal erectile function through 36 months [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]*Cardiovascular events include - CVA, MI, narrowing of a coronary or peripheral artery resulting in revascularization, new onset hypertension, unstable angina and/or cardiovascular death
- The predictive capacity of ED for incident cardiovascular events* compared to men without ED found to have healthy pelvic vasculature (< 50% stenosis in erectile relevant arteries) through 36 months [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]*Cardiovascular events include - CVA, MI, narrowing of a coronary or peripheral artery resulting in revascularization, new onset hypertension, unstable angina and/or cardiovascular death
- Evaluation of the Urological Assessment Survey (UAS) from baseline through the 36 month follow-up period [ Time Frame: 36 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Vascular insufficiency is a commonly cited cause of Erectile Dysfunction (ED) and the most common treatments of ED target aspects of the penile vasculature. Initial pharmacotherapy typically focuses on the penile microvasculature; however, surgical revascularization has also been used to treat ED caused by lesions in the internal iliac artery (IIA) and/or internal pudendal artery (IPA) and penile arteries. Anatomically, surgical revascularization connects the inferior epigastric artery to the dorsal artery of the penis or a combination of the dorsal artery and vein of the penis. The pudendal artery or deep artery of the penis is usually not the target of surgical bypass. Recent advances in percutaneous revascularization have sparked interest in penile revascularization to treat ED.
However, as this new percutaneous treatment modality evolves, several important clinical questions remain unanswered. Important among these are what is the normal angiographic anatomy of the erectile related arteries (ERA), and how do angiographic findings correlate with symptoms of ED? Also, how many men could possible benefit from percutaneous revascularization?
The normal IPA anatomy by contrast angiography is not well defined and there are no studies that correlate IPA findings with erectile function. While studies have been done on populations of men with suspected vasculogenic and chronic ED, no study has established the normal angiographic anatomy of the IPA or evaluated the prevalence of angiographic IPA occlusive disease.
Therefore, an angiographic prevalence study will assist in determining the population of men who could potentially benefit from percutaneous treatment of atherosclerotic IPA lesions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341483
|United States, Illinois|
|Prairie Edication and Research Cooperative|
|Springfield, Illinois, United States, 62701|
|Principal Investigator:||Krishna Rocha-Singh, MD||Prairie Cardiovascular Consultants|