NCT07856199Recruiting
Pudendal Atherosclerosis by IVUS-NIRS in Men With Coronary Artery Disease
Characterization of Internal Pudendal Atherosclerosis by Intravascular Ultrasound and Near-Infrared Spectroscopy and Its Relationship With Erectile Dysfunction in Men With Coronary Artery Disease
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
This prospective, single-center, exploratory study will evaluate the association between atherosclerotic and lipid plaque burden in the internal pudendal arteries, assessed by intravascular ultrasound and near-infrared spectroscopy (IVUS-NIRS), and the severity of erectile dysfunction in adult men with documented or suspected coronary artery disease undergoing clinically indicated coronary angiography. After completion of the clinically indicated coronary procedure, eligible and hemodynamically stable participants with favorable pelvic vascular anatomy will undergo selective pudendal angiography and investigational IVUS-NIRS imaging of one or both internal pudendal arteries. Erectile function will subsequently be assessed within 30 days using the 5-item International Index of Erectile Function (IIEF-5). The primary outcome will be the correlation between pudendal maxLCBI4mm and IIEF-5 score. Secondary analyses will characterize pudendal and coronary plaque burden, assess the relationship between pudendal and coronary lipid burden, evaluate associations with cardiovascular risk factors, and describe the technical feasibility and safety of pudendal IVUS-NIRS imaging.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Sept 2026
- Start date
- 24 Sept 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Hospital Central Militar
- Diseases
- Coronary artery disease
- NCT number
- NCT07856199
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 24 Sept 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Advanced prostate cancer or previous urologic treatment that predominantly explains erectile dysfunction.
Other illness
- Advanced kidney disease or high risk of kidney injury associated with additional contrast administration.
- Severe coagulopathy, active bleeding, or contraindication to the invasive procedure.
- History of radical pelvic surgery or pelvic radiotherapy.
- Severe untreated hypogonadism, advanced neurologic disease, or another predominant nonvascular cause of erectile dysfunction.
Other
- Cardiogenic shock, hemodynamic instability, or acute clinical deterioration.
- Urgent or complicated coronary procedure in which prolonging the procedure would increase risk.
- Unfavorable iliofemoral or pelvic vascular anatomy for safe evaluation of the internal pudendal arteries.
- Inability to reliably complete the IIEF-5 questionnaire.
- Refusal to participate or to provide study-specific written informed consent.
Who the study is looking for
- Male participants aged 18 years or older.
- Documented or suspected coronary artery disease with a clinical indication for coronary angiography.
- Coronary IVUS-NIRS evaluation indicated by the treating interventional cardiologist.
- Sufficient clinical and hemodynamic stability to undergo the additional pudendal evaluation.
- Favorable pelvic vascular anatomy for selective angiography and safe advancement of the IVUS-NIRS catheter.
- Ability to complete the IIEF-5 questionnaire and provide information regarding sexual function.
- Written informed consent specifically for study participation and invasive evaluation of the internal pudendal arteries.
- Agreement to clinical follow-up by Cardiology and Urology.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Central Militar Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.