Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study

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