Erectile Dysfunction Due to Arterial InsufficiencyIMPASSENCT01341483
Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study
An observational study of Erectile Dysfunction Due to Arterial Insufficiency, run by Medtronic Endovascular at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction Due to Arterial Insufficiency
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Prairie Edication and Research Cooperative
Springfield, Illinois, 62701
About this 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).
Read the 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.
- Keywords
- erectile dysfunction, internal pudendal artery, erection, coronary artery disease, peripheral atherosclerotic disease
- Medical subject headings
- Erectile Dysfunction, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline through Discharge
Secondary outcomes (7)
Procedural Safety
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
Measured: 30 Days
To determine the proportion of men with atherosclerotic ERA disease who have erectile dysfunction (ED) through 36 months
ED is defined as a urological assessment survey (UAS) of less than or equal to 21
Measured: 36 months
To determine the proportion of men who have atherosclerotic ERA disease and are asymptomatic (i.e., normal erectile function) through 36 months
Normal erectile function is defined as a UAS score greater than 21
Measured: 36 months
To determine the proportion of men who have ED without evidence of atherosclerotic ERA disease through 36 months
Measured: 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
*Cardiovascular events include - CVA, MI, narrowing of a coronary or peripheral artery resulting in revascularization, new onset hypertension, unstable angina and/or cardiovascular death
Measured: 36 months
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
*Cardiovascular events include - CVA, MI, narrowing of a coronary or peripheral artery resulting in revascularization, new onset hypertension, unstable angina and/or cardiovascular death
Measured: 36 months
Evaluation of the Urological Assessment Survey (UAS) from baseline through the 36 month follow-up period
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Sufficient information gathered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Due to Arterial InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Krishna Rocha-Singh, MD, Principal investigator, Prairie Cardiovascular Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341483
- Sponsor's protocol ID
- 00110-229
- Acronym
- IMPASSE
- Status last verified
- Jan 2016
- First submitted
- 20 Apr 2011
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study
- ClinicalTrials.gov ID
- NCT01341483
- Acronym / sponsor ID
- IMPASSE / 00110-229
- Keywords
- erectile dysfunction, internal pudendal artery, erection, coronary artery disease, peripheral atherosclerotic disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sufficient information gathered
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
7 secondary outcomes
Procedural Safety
Time frame: 30 Days
To determine the proportion of men with atherosclerotic ERA disease who have erectile dysfunction (ED) through 36 months
Time frame: 36 months
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
To determine the proportion of men who have ED without evidence of atherosclerotic ERA disease through 36 months
Time frame: 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
Time frame: 36 months
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
Evaluation of the Urological Assessment Survey (UAS) from baseline through the 36 month follow-up period
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Sufficient information gathered). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krishna Rocha-Singh, MD principal investigator
Prairie Cardiovascular Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction Due to Arterial Insufficiency, run by Medtronic Endovascular at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sufficient information gathered). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.