Status:
UNKNOWN
Sirolimus Eluting Balloon Utilization for Treatment of Vasculogenic Erectile Dysfunction
Lead Sponsor:
Clinica San Gaudenzio
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
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 i...
Detailed Description
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 quali...
Eligibility Criteria
Inclusion
- 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 \<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
- Angiographic exclusion criteria
- Vessel size \< 1.5 mm by visual estimation.
- Lesion length \> 80 mm by visual estimation.
- Restenosis from previous intervention
- Thrombus, or possible thrombus, present in the target vessel
- Previous implantation of a bare/DES in the target vessel
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04345965
Start Date
September 1 2019
End Date
December 1 2023
Last Update
December 28 2022
Active Locations (1)
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1
Policlinico Tor Vergata
Rome, Lazio, Italy, 00133