Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study (IMPASSE)

This study has been terminated.
(Sufficient information gathered)
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01341483
First received: April 20, 2011
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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).


Condition
Erectile Dysfunction Due to Arterial Insufficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • To determine the proportion of men with known or suspected CAD and/or PAD that have angiographic identifiable erectile related artery (ERA) atherosclerotic disease [ Time Frame: Baseline through Discharge ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Procedural Safety [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Defined as major adverse event (MAE) rate at 30 days characterized as: 1) Procedure related death (directly related to the ERA DSA portion of the baseline angiography) 2) Occurrence of perineal gangrene or necrosis (penile glans, penile shaft, scrotal or anal) 3) Perineal, penile or anal surgery (including ERA embolization procedures) 4) Renal failure

  • To determine the proportion of men with atherosclerotic ERA disease who have erectile dysfunction (ED) through 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    ED is defined as a urological assessment survey (UAS) of less than or equal to 21

  • To determine the proportion of men who have atherosclerotic ERA disease and are asymptomatic (i.e., normal erectile function) through 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Normal erectile function is defined as a UAS score greater than 21

  • To determine the proportion of men who have ED without evidence of atherosclerotic ERA disease through 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • The predictive capacity of ERA atherosclerosis for potential future cardiovascular events* including ED in men with baseline normal erectile function through 36 months [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    *Cardiovascular events include - CVA, MI, narrowing of a coronary or peripheral artery resulting in revascularization, new onset hypertension, unstable angina and/or cardiovascular death

  • The predictive capacity of ED for incident cardiovascular events* compared to men without ED found to have healthy pelvic vasculature (< 50% stenosis in erectile relevant arteries) through 36 months [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    *Cardiovascular events include - CVA, MI, narrowing of a coronary or peripheral artery resulting in revascularization, new onset hypertension, unstable angina and/or cardiovascular death

  • Evaluation of the Urological Assessment Survey (UAS) from baseline through the 36 month follow-up period [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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) 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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341483

Locations
United States, Illinois
Prairie Edication and Research Cooperative
Springfield, Illinois, United States, 62701
Sponsors and Collaborators
Medtronic Endovascular
Medtronic
Investigators
Principal Investigator: Krishna Rocha-Singh, MD Prairie Cardiovascular Consultants
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01341483     History of Changes
Other Study ID Numbers: 00110-229
Study First Received: April 20, 2011
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Endovascular:
erectile dysfunction
internal pudendal artery
erection
coronary artery disease
peripheral atherosclerotic disease

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014