Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study
Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study
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).
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.
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 compromise the safety of the subject by
 proceeding with enrollment into the IMPASSE study