Sirolimus Eluting Balloon Utilization for Treatment of Vasculogenic Erectile Dysfunction (NCT04345965) | Clinical Trial Compass
UnknownNot Applicable
Sirolimus Eluting Balloon Utilization for Treatment of Vasculogenic Erectile Dysfunction
Italy100 participantsStarted 2019-09-01
Plain-language summary
Brief Summary:
Background and pathophysiology: Erectile dysfunction (ED) is defined as the recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse.
ED is not in itself a "serious" disease, but its impact on quality of life is extremely important, affecting the family and interpersonal relationships.
Male erection is a complex mechanism that involves neuro-vascular tissue responses with several phases including arterial dilatation, smooth muscle cells relaxation and ultimately veno-occlusive activation.
Vasculogenic erectile dysfunction can be divided in arteriogenic (when there is insufficiency of arterial component of erection due to atherosclerotic plaque encroachment of the penile arteries) or venogenic (where there is insufficiency of the venous component of erection for venous endoleak) Standard treatment Erectile dysfunction is commonly treated by oral phosphodiesterase-5-inhibitor (PDE5i) administration. However, up to 50% of men have a suboptimal response to PDE5-i therapy with the need of additional therapies. New treatment Only recently several studies have been published on percutaneous treatment of ED using plain old balloon angioplasty (POBA), Drug eluting balloons (both paclitaxel and sirolimus, PEB and SES) and drug eluting stents (DES).
Aim of the study: Evaluation of the safety and feasibility of sirolimus drug eluting balloon treatment in focal atherosclerotic lesions of the internal pudendal arteries among men with erectile dysfunction (ED) and a no response to phosphodiesterase-5 inhibitors.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Male able to understand and sign a witnessed informed consent for the procedure
* Age \>18 years
* Eligibility for percutaneous peripheral intervention
* Patients with ED evaluated by International Index of Erectile Function- (IIEF)-5 score \< 15, positive dynamic doppler (PSV \<25 cm/sec) and/or evidence at basal CT angiography of single or multiple atherosclerotic lesions in the pudendal arteries
* Hemodynamic conditions must be stable (systolic BP \> 100 heart rate (HR) \> 40 \< 100).
* Left ventricular ejection fraction (LVEF) ≥40% as measured prior to enrollment.
* No response to any dosage of PDE5i for more than 6 mos before enrollment (either chronic or on-demanding).
Angiographic inclusion criteria
* Target lesions must be de novo lesions located in at least one native pudendal artery with a visually estimated reference vessel diameter (RVD) 1.5 mm and 2.5 mm.
* If two lesions in the same vessel are treated, overlapping balloon treatment is allowed.
* Target lesion must be in the pudendal arteries or dorsalis penis with visually estimated stenosis \>70% and \<100%.
Exclusion Criteria:
* Ejection Fraction below 40%
* Hemodynamic instability (systolic blood pressure \<100 mm Hg; heart rate \<40 bpm or \>100 bpm; complex ventricular arrhythmias; AtrioVentricular (AV) block) requiring balloon counterpulsation or inotropic support.
* Patient was never treated with PDE5i
* Patient has not performed a basal and dynamic pelvic Doppler
* Patient has a platelet count \<10…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of Delta International Index of Erectile Function IEF-5 score between basal and 8 months FU (>5)