Safety and Feasibility of the Zotarolimus Stent in Treating Males With Erectile Dysfunction (ED) (ZEN)

Inclusion Criteria:

• Males ≥ 18 years old in a stable heterosexual relationship for a minimum of 6 months prior to providing consent to participate in this study;
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective investigational site;
• The subject has successfully completed the 4 week run-in phase;
• The subject has a mean PSV of the right and left cavernosal arteries;
• The subject has angiographic evidence of an atherosclerotic stenosis of the internal iliac or internal pudendal artery;
• The subject is able and willing to comply with all study requirements, including the follow-up evaluations and will return to the investigational site(s) for all required office visits.

Exclusion Criteria:

• The subject has a life expectancy < 12 months;
• The subject has erectile dysfunction associated with non-vascular (organic) etiology (i.e., psychogenic, mixed, neurologic abnormalities, untreated hormonal dysfunction, etc.);
• The subject has untreated depression or hypertension;
• The subject has any penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease) that in the investigator's opinion would impair sexual performance;
• The subject's partner, according to the subject, has complaints of overall health such as cardiovascular or mental health concerns, or specific sexual health problems such as sexual interest, sexual arousal, orgasm or sexual pain issues;
• The subject has a history of myocardial infarction, stroke or life-threatening arrhythmia, or unstable angina requiring hospitalization within 3 months prior to enrollment or is actively receiving nitrate therapy;
• The subject has a known allergy or contraindication to any component (material, drug and/or polymer) of the stent system, aspirin, heparin or phenylepherine and/or a sensitivity to contrast media which cannot be adequately pre-medicated and/or is allergic to both clopidogrel and ticlopidine;
• The subject has poorly controlled diabetes mellitus;
• The subject has a history of bleeding diatheses or coagulopathy or will refuse blood transfusions;
• The subject has received chemotherapy treatment within 12 months prior to enrollment;
• The subject has a history of prior radiation therapy to the pelvic region, radical prostatectomy or cystectomy;
• The subject has untreated hypogonadism;
• The subject has known impaired renal function;
• The subject has taken sildenafil or vardenafil within 24 hours or tadalafil within 36 hours prior to enrollment in the study;
• The subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.