Sirolimus Eluting Balloon Utilization for Treatment of Vasculogenic Erectile Dysfunction

NCT04345965 | Unknown DMC

• 1 other identifier: SUASION
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Keywords

ED

Outcome Measures

Primary Outcomes (1)

• Evaluation of Delta International Index of Erectile Function IEF-5 score between basal and 8 months FU (>5)

  The score 22-25 means normal function The score 17-21 means very light erectile disfunction The score 12-16 means light to moderate erectile disfunction The score 8-11 means moderate erectile disfunction The score 5-7 means severe erectile disfunction Delta PSV (\>8) at the Dynamic Doppler evaluation between basal and 8 mos follow-up

  1-8 months

Secondary Outcomes (3)

• Number of participants Reporting Any Medically Attended Adverse Events (MAEs)

  1-24 months

• The rate of Binary Restenosis

  1, 6, 12, 24 months

• Angiographic in-stent late loss measure

  1, 6, 12, 24 months

Study Arms (1)

Active endovascular treatment

Patients with erectile dysfunction (ED) and no-response to phosphodiesterase-5 inhibitors for at least 6 months before enrollment

Procedure: Endovascular procedure

Interventions

Endovascular procedure PROCEDURE

Endovascular therapies for erectile dysfunction

Active endovascular treatment

Eligibility Criteria

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

Study Population

Patients with erectile dysfunction (ED) and no-response to phosphodiesterase-5 inhibitors for at least 6 months before enrollment

You may qualify if:

• 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%.

You may not qualify if:

• 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 \<100,000 cells/mm3 or \>700,000 cells/mm3
• Patient has a white blood cell (WBC) count \<3,000 cells/mm3
• Patient is on dialysis or has known renal insufficiency (serum creatinine \> 2 mg/dl, or Glomerular Filtration Rate (GFR) \<40)
• Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
• Patient has a known allergy to Sirolimus or protocol required concomitant medications (clopidogrel, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
• Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding
• Patient has a history of coagulopathy
• Patient has other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
• Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
• Vessel size \< 1.5 mm by visual estimation.
• Lesion length \> 80 mm by visual estimation.

Sponsors & Collaborators

• Clinica San Gaudenzio: lead

Study Sites (1)

Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

RECRUITING

Related Publications (61)

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MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Endovascular Procedures

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Giuseppe Sangiorgi, MD

CONTACT

+393355851101; gsangiorgi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 15, 2020
• Study Start: September 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)