Coronary Artery DiseasePUDENDAL-NIRSNCT07856199
Pudendal Atherosclerosis by IVUS-NIRS in Men With Coronary Artery Disease
A study testing Selective Pudendal Angiography and Pudendal IVUS-NIRS Imaging in people with Coronary Artery Disease and Erectile Dysfunction, run by Hospital Central Militar at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Coronary Artery Disease, Erectile Dysfunction, Atherosclerosis
- What is being tested?
- Selective Pudendal Angiography and Pudendal IVUS-NIRS Imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 24 Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Central Militar
Mexico City, Mexico City, 11200
José Raúl Méndez Colin, MD, +52 55 2516 3465, dr.mendezcolin1989@gmail.com
Luis Enrique Berumen Domínguez, MD, luisberumen@hotmail.com
About this study
Official title: Characterization of Internal Pudendal Atherosclerosis by Intravascular Ultrasound and Near-Infrared Spectroscopy and Its Relationship With Erectile Dysfunction in Men With Coronary Artery Disease
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.
- Being tested
- Selective Pudendal Angiography, Pudendal IVUS-NIRS Imaging
- Keywords
- Internal Pudendal Artery, Intravascular Ultrasound, Near-Infrared Spectroscopy, IVUS-NIRS, Lipid Core Burden Index, maxLCBI4mm, IIEF-5
- Medical subject headings
- Coronary Artery Disease, Erectile Dysfunction, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Pudendal AngiographyProcedure or surgery
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 ImagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Selective Pudendal Angiography; Device: Pudendal IVUS-NIRS Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: During the pudendal IVUS-NIRS procedure
Pudendal Artery Lipid Burden by NIRS
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.
Measured: During the index pudendal IVUS-NIRS procedure
Correlation Between Pudendal and Coronary maxLCBI4mm
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.
Measured: During the index coronary and pudendal IVUS-NIRS procedures
Pudendal Atherosclerotic and Lipid Burden According to Erectile Dysfunction Severity
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.
Measured: Within 30 days after enrollment
Spearman Correlation Between Pudendal maxLCBI4mm and LDL Cholesterol
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.
Measured: At baseline
Number of Participants With Successful Pudendal IVUS-NIRS Image Acquisition
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.
Measured: Periprocedural
Procedure-Related Adverse Events
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.
Measured: From the pudendal procedure through the 30-day study evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start24 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Central Militar
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- José Raúl Méndez Colin, MD, Principal investigator, Hospital Central MilitarLuis Enrique Berumen Domínguez, MD, Study director, Hospital Central Militar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856199
- Sponsor's protocol ID
- HCM-PUDENDAL-NIRS-2026
- Acronym
- PUDENDAL-NIRS
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study protocol and informed consent do not include a plan for external sharing of participant-level data. Study data will remain under institutional custody and will be used for the approved research objectives, analyses, and scientific publications while maintaining participant confidentiality.
Publications
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.
PubMed 16854949Rosen 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.
PubMed 10637462Erlinge 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.
PubMed 33714389Waksman 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.
PubMed 31570255Zacharias 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.
PubMed 26957574Rogers 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.
PubMed 20928837Park 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.
PubMed 31714923
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Internal Pudendal Atherosclerosis by Intravascular Ultrasound and Near-Infrared Spectroscopy and Its Relationship With Erectile Dysfunction in Men With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07856199
- Acronym / sponsor ID
- PUDENDAL-NIRS / HCM-PUDENDAL-NIRS-2026
- Keywords
- Internal Pudendal Artery, Intravascular Ultrasound, Near-Infrared Spectroscopy, IVUS-NIRS, Lipid Core Burden Index, maxLCBI4mm, IIEF-5
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Central MilitarOther government
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pudendal IVUS-NIRS Evaluation | Experimental | Procedure: Selective Pudendal Angiography, Device: Pudendal IVUS-NIRS ImagingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Pudendal AngiographySelective 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. | Procedure or surgery | Pudendal IVUS-NIRS Evaluation |
| Pudendal IVUS-NIRS ImagingWhen 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. | Device | Pudendal IVUS-NIRS Evaluation |
Primary outcome
Correlation Between Pudendal maxLCBI4mm and IIEF-5 Score
Time frame: 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.
7 secondary outcomes
Pudendal Artery Plaque Burden by IVUS
Time frame: During the pudendal IVUS-NIRS procedure
Pudendal Artery Lipid Burden by NIRS
Time frame: During the index pudendal IVUS-NIRS procedure
Correlation Between Pudendal and Coronary maxLCBI4mm
Time frame: During the index coronary and pudendal IVUS-NIRS procedures
Pudendal Atherosclerotic and Lipid Burden According to Erectile Dysfunction Severity
Time frame: Within 30 days after enrollment
Spearman Correlation Between Pudendal maxLCBI4mm and LDL Cholesterol
Time frame: At baseline
Number of Participants With Successful Pudendal IVUS-NIRS Image Acquisition
Time frame: Periprocedural
Procedure-Related Adverse Events
Time frame: From the pudendal procedure through the 30-day study evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 16854949Montorsi 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.
- Background: PubMed 10637462Rosen 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.
- Background: PubMed 33714389Erlinge 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.
- Background: PubMed 31570255Waksman 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.
- Background: PubMed 26957574Zacharias 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.
- Background: PubMed 20928837Rogers 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.
- Background: PubMed 31714923Park 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study protocol and informed consent do not include a plan for external sharing of participant-level data. Study data will remain under institutional custody and will be used for the approved research objectives, analyses, and scientific publications while maintaining participant confidentiality.
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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.
José Raúl Méndez Colin, MD principal investigator
Hospital Central Militar
Luis Enrique Berumen Domínguez, MD study director
Hospital Central Militar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Pudendal Angiography and Pudendal IVUS-NIRS Imaging in people with Coronary Artery Disease and Erectile Dysfunction, run by Hospital Central Militar at 1 site in Mexico.
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 8 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Raúl Méndez Colin, MD (+52 55 2516 3465, dr.mendezcolin1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Pudendal maxLCBI4mm and IIEF-5 Score (time frame: At the pudendal IVUS-NIRS procedure and within 30 days after enrollment for IIEF-5 assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07856199, which also lists 7 linked publications.
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 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.