NCT01341483

Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: Male
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Erectile Dysfunction Due to Arterial Insufficiency

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-04-25
• Last updated: 2016-02-01

Locations

1 site across 1 country: United States