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NCT04345965: SUASION
Sirolimus Eluting Balloon Utilization for Treatment of Vasculogenic Erectile Dysfunction
trial testing Endovascular procedure in Erectile Dysfunction in 100 participants. Status unknown.
1 December 2023
Quick facts
| Lead sponsor | Clinica San Gaudenzio |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 September 2019 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Endovascular procedure
Conditions studied
- Erectile Dysfunction — all drugs for Erectile Dysfunction →
Sponsor
Clinica San Gaudenzio
Who can join
18 and older, male only, with Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04345965
- Europe PMC full search
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Related trials
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Trials testing the same drug.
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Other recruiting trials for Erectile Dysfunction
Currently open trials in the same condition.
- NCT07442396 — The Effectiveness of Exercise in the Treatment of Erectile Dysfunction and Premature Ejaculation · NA · recruiting
- NCT07366970 — Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D? · NA · recruiting
- NCT06960746 — Changing Lifestyle in OSA Males Who Suffer Metabolic Syndrome and Impotence: Is There a Response? · NA · recruiting
- NCT06872866 — The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under · Phase 1 · recruiting
- NCT06805513 — Actual Use Trial of Tadalafil 5 mg · Phase 3 · recruiting
Other Clinica San Gaudenzio trials
Trials by the same sponsor.
- NCT04333173 — Endovascular Therapy for Erectile Dysfunction · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04345965 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Clinica San Gaudenzio
- Last refreshed: 28 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04345965.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing