Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study

NCT01341483 | Terminated

• 1 other identifier: 00110-229
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Erectile Dysfunction Due to Arterial Insufficiency

Keywords

erectile dysfunction; internal pudendal artery; erection; coronary artery disease; peripheral atherosclerotic disease

Outcome Measures

Primary Outcomes (1)

• To determine the proportion of men with known or suspected CAD and/or PAD that have angiographic identifiable erectile related artery (ERA) atherosclerotic disease

  Identifiable ERA disease is defined as at least one ERA stenosis greater than or equal to 50 percent (per core lab Quantitative Vascular Analysis - QVA)

  Baseline through Discharge

Secondary Outcomes (7)

• Procedural Safety

  30 Days

• To determine the proportion of men with atherosclerotic ERA disease who have erectile dysfunction (ED) through 36 months

  36 months

• To determine the proportion of men who have atherosclerotic ERA disease and are asymptomatic (i.e., normal erectile function) through 36 months

  36 months

• To determine the proportion of men who have ED without evidence of atherosclerotic ERA disease through 36 months

  36 months

• The predictive capacity of ERA atherosclerosis for potential future cardiovascular events* including ED in men with baseline normal erectile function through 36 months

  36 months

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of male subjects 35 - 70 years of age undergoing coronary or peripheral angiography and/or intervention for suspected or known coronary or peripheral atherosclerotic disease (CAD or PAD).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Endovascular: lead
• Medtronic: collaborator

Study Sites (1)

Prairie Edication and Research Cooperative

Springfield, Illinois, 62701, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Krishna Rocha-Singh, MD

  Prairie Cardiovascular Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 25, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

US (1)