Pudendal Atherosclerosis by IVUS-NIRS in Men With Coronary Artery Disease

NCT07856199 | Recruiting

• 1 other identifier: HCM-PUDENDAL-NIRS-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Erectile Dysfunction; Atherosclerosis

Keywords

Internal Pudendal Artery; Intravascular Ultrasound; Near-Infrared Spectroscopy; IVUS-NIRS; Lipid Core Burden Index; maxLCBI4mm; IIEF-5

Outcome Measures

Primary Outcomes (1)

• Correlation Between Pudendal maxLCBI4mm and IIEF-5 Score

  The association between the maximum lipid core burden index within a 4-mm segment (maxLCBI4mm) of the internal pudendal arteries, measured by IVUS-NIRS, and erectile function assessed by the 5-item International Index of Erectile Function (IIEF-5) will be evaluated using Spearman correlation. Pudendal maxLCBI4mm ranges from 0 to 1000, with higher values indicating greater lipid burden. IIEF-5 scores range from 5 to 25, with lower scores indicating more severe erectile dysfunction.

  At the pudendal IVUS-NIRS procedure and within 30 days after enrollment for IIEF-5 assessment

Secondary Outcomes (7)

• Pudendal Artery Plaque Burden by IVUS

  During the pudendal IVUS-NIRS procedure

• Pudendal Artery Lipid Burden by NIRS

  During the index pudendal IVUS-NIRS procedure

• Correlation Between Pudendal and Coronary maxLCBI4mm

  During the index coronary and pudendal IVUS-NIRS procedures

• Pudendal Atherosclerotic and Lipid Burden According to Erectile Dysfunction Severity

  Within 30 days after enrollment

• Spearman Correlation Between Pudendal maxLCBI4mm and LDL Cholesterol

  At baseline

Study Arms (1)

Pudendal IVUS-NIRS Evaluation

EXPERIMENTAL

Participants will undergo selective angiography of the internal iliac and internal pudendal arteries followed, when technically feasible and clinically safe, by investigational IVUS-NIRS imaging of one or both internal pudendal arteries.

Procedure: Selective Pudendal Angiography; Device: Pudendal IVUS-NIRS Imaging

Interventions

Selective Pudendal Angiography PROCEDURE

Selective angiography of the internal iliac and internal pudendal arteries will be performed after completion of the clinically indicated coronary procedure to assess pelvic vascular anatomy and technical feasibility for intravascular imaging.

Pudendal IVUS-NIRS Evaluation

Pudendal IVUS-NIRS Imaging DEVICE

When vascular anatomy and clinical conditions are considered suitable, an IVUS-NIRS catheter will be advanced into one or both internal pudendal arteries. Automated pullback imaging will be performed to assess vessel anatomy, plaque burden, lipid core burden index (LCBI), and maxLCBI4mm.

Pudendal IVUS-NIRS Evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cardiogenic shock, hemodynamic instability, or acute clinical deterioration.
• Urgent or complicated coronary procedure in which prolonging the procedure would increase risk.
• Advanced kidney disease or high risk of kidney injury associated with additional contrast administration.
• Unfavorable iliofemoral or pelvic vascular anatomy for safe evaluation of the internal pudendal arteries.
• Severe coagulopathy, active bleeding, or contraindication to the invasive procedure.
• History of radical pelvic surgery or pelvic radiotherapy.
• Advanced prostate cancer or previous urologic treatment that predominantly explains erectile dysfunction.
• Severe untreated hypogonadism, advanced neurologic disease, or another predominant nonvascular cause of erectile dysfunction.
• Inability to reliably complete the IIEF-5 questionnaire.
• Refusal to participate or to provide study-specific written informed consent.

Sponsors & Collaborators

• Hospital Central Militar: lead

Study Sites (1)

Hospital Central Militar

Mexico City, Mexico City, 11200, Mexico

RECRUITING

Related Publications (7)

• Montorsi P, Ravagnani PM, Galli S, Rotatori F, Veglia F, Briganti A, Salonia A, Deho F, Rigatti P, Montorsi F, Fiorentini C. Association between erectile dysfunction and coronary artery disease. Role of coronary clinical presentation and extent of coronary vessels involvement: the COBRA trial. Eur Heart J. 2006 Nov;27(22):2632-9. doi: 10.1093/eurheartj/ehl142. Epub 2006 Jul 19.

  PMID: 16854949 BACKGROUND

• Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.

  PMID: 10637462 BACKGROUND

• Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.

  PMID: 33714389 BACKGROUND

• Waksman R, Di Mario C, Torguson R, Ali ZA, Singh V, Skinner WH, Artis AK, Cate TT, Powers E, Kim C, Regar E, Wong SC, Lewis S, Wykrzykowska J, Dube S, Kazziha S, van der Ent M, Shah P, Craig PE, Zou Q, Kolm P, Brewer HB, Garcia-Garcia HM; LRP Investigators. Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019 Nov 2;394(10209):1629-1637. doi: 10.1016/S0140-6736(19)31794-5. Epub 2019 Sep 27.

  PMID: 31570255 BACKGROUND

• Zacharias SK, Safian RD, Madder RD, Hanson ID, Pica MC, Smith JL, Goldstein JA, Abbas AE. Invasive evaluation of plaque morphology of symptomatic superficial femoral artery stenoses using combined near-infrared spectroscopy and intravascular ultrasound. Vasc Med. 2016 Aug;21(4):337-44. doi: 10.1177/1358863X16631420. Epub 2016 Mar 8.

  PMID: 26957574 BACKGROUND

• Rogers JH, Karimi H, Kao J, Link D, Javidan J, Yamasaki DS, Dolan M, Laird JR, Low RI. Internal pudendal artery stenoses and erectile dysfunction: correlation with angiographic coronary artery disease. Catheter Cardiovasc Interv. 2010 Nov 15;76(6):882-7. doi: 10.1002/ccd.22646. Epub 2010 Oct 6.

  PMID: 20928837 BACKGROUND

• Park HW, Her SH, Park BH, Han DS, Yuk SM, Kim DW, Youn CS, Jang H. Correlation between internal pudendal artery stenosis and erectile dysfunction in patients with suspected coronary artery disease. PLoS One. 2019 Nov 12;14(11):e0225179. doi: 10.1371/journal.pone.0225179. eCollection 2019.

  PMID: 31714923 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Erectile Dysfunction; Atherosclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• José Raúl Méndez Colin, MD

  Hospital Central Militar

  PRINCIPAL INVESTIGATOR

• Luis Enrique Berumen Domínguez, MD

  Hospital Central Militar

  STUDY DIRECTOR

Central Study Contacts

José Raúl Méndez Colin, MD

CONTACT

+52 55 2516 3465; dr.mendezcolin1989@gmail.com

Luis Enrique Berumen Domínguez, MD

CONTACT

+52 55 2122 1100; luisberumen@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 2, 2026
• Study Start: September 24, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)