Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01341483
Status:
TERMINATED
Last Update Posted:
2016-02-01
First Post:
2011-04-20
Brief Title:
Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study
Sponsor:
Medtronic Endovascular
Organization:
Medtronic Endovascular
Study Overview
Official Title:
Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sufficient information gathered
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPASSE
Brief Summary:
The purpose of this study is to determine the proportion of men with known or suspected coronary artery disease CAD andor 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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None