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

• 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 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.

Primary outcomes

• Correlation Between Pudendal maxLCBI4mm and IIEF-5 Score [At the pudendal IVUS-NIRS procedure and within 30 days after enrollment for IIEF-5 assessment]: 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.

Secondary outcomes

• Pudendal Artery Plaque Burden by IVUS [During the pudendal IVUS-NIRS procedure]: Pudendal artery plaque burden will be quantified by intravascular ultrasound (IVUS) as the proportion of the vessel area occupied by plaque plus media. Measurements will include plaque burden, minimum lumen area, and angiographic percent stenosis in the evaluated internal pudendal arteries.
• Pudendal Artery Lipid Burden by NIRS [During the index pudendal IVUS-NIRS procedure]: Lipid burden in the internal pudendal arteries will be characterized using near-infrared spectroscopy (NIRS), including the Lipid Core Burden Index (LCBI) and maximum LCBI within any continuous 4-mm segment (maxLCBI4mm). If both internal pudendal arteries are evaluated, measurements from each side will be recorded and the highest maxLCBI4mm per participant will be used for the main analyses.
• Correlation Between Pudendal and Coronary maxLCBI4mm [During the index coronary and pudendal IVUS-NIRS procedures]: The association between pudendal and coronary lipid burden will be assessed by correlating the highest pudendal maxLCBI4mm with the highest coronary maxLCBI4mm obtained by IVUS-NIRS. The correlation will be evaluated using Spearman correlation.
• Pudendal Atherosclerotic and Lipid Burden According to Erectile Dysfunction Severity [Within 30 days after enrollment]: Pudendal atherosclerotic and lipid burden, including plaque burden and maxLCBI4mm, will be compared across erectile dysfunction severity categories defined by the IIEF-5 score: no erectile dysfunction, mild, mild-to-moderate, moderate, and severe erectile dysfunction.
• Spearman Correlation Between Pudendal maxLCBI4mm and LDL Cholesterol [At baseline]: Spearman's rank correlation coefficient (rho) will be calculated between pudendal maxLCBI4mm measured by near-infrared spectroscopy (NIRS) and serum low-density lipoprotein cholesterol (LDL-C). Pudendal maxLCBI4mm is expressed as an index from 0 to 1000, with higher values indicating greater lipid burden. LDL-C is expressed in mg/dL.
• Number of Participants With Successful Pudendal IVUS-NIRS Image Acquisition [Periprocedural]: The number of participants in whom analyzable IVUS-NIRS images are successfully obtained from at least one internal pudendal artery will be reported. Successful image acquisition is defined as acquisition of images of sufficient quality for quantitative IVUS and NIRS analysis.
• Procedure-Related Adverse Events [From the pudendal procedure through the 30-day study evaluation]: Adverse events related to selective pudendal angiography and IVUS-NIRS imaging will be recorded, including arterial dissection, perforation, persistent vasospasm, thrombosis, bleeding, contrast-associated kidney injury, embolization, or other complications considered attributable to the investigational pudendal procedure.

Sex: Male, ages: 18 Years to any

Inclusion Criteria:

1. Male participants aged 18 years or older.
2. Documented or suspected coronary artery disease with a clinical indication for coronary angiography.
3. Coronary IVUS-NIRS evaluation indicated by the treating interventional cardiologist.
4. Sufficient clinical and hemodynamic stability to undergo the additional pudendal evaluation.
5. Favorable pelvic vascular anatomy for selective angiography and safe advancement of the IVUS-NIRS catheter.
6. Ability to complete the IIEF-5 questionnaire and provide information regarding sexual function.
7. Written informed consent specifically for study participation and invasive evaluation of the internal pudendal arteries.
8. Agreement to clinical follow-up by Cardiology and Urology.

Exclusion Criteria:

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

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• José Raúl Méndez Colin, MD, Principal investigator, Hospital Central Militar
• Luis Enrique Berumen Domínguez, MD, Study director, Hospital Central Militar