Status:
COMPLETED
Endovascular Therapy for Erectile Dysfunction
Lead Sponsor:
Clinica San Gaudenzio
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Brief Summary
Brief Summary: Background and pathophysiology Erectile dysfunction is a serious disease with a significant impact on the quality of life. Male erection is a complex mechanism that involves neuro-vascu...
Detailed Description
Detailed Description: The objective of this study is to evaluate of the safety and feasibility of endovascular therapies in segmental atherosclerotic lesions of the internal pudendal arteries among me...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Be able to understand and sign a witnessed informed consent for the procedure
- Eligibility for percutaneous peripheral intervention
- Baseline IIEF-5 score evaluation \< 15
- PSV \< 25 cm/sec
- Stable hemodynamic conditions
- Normal ejection fraction
- Being refractory to oral PDE5-I for at least 6 months before enrollement
- Treatable angiographic lesions of the pudendal arteries
Exclusion
- Heart failure
- Hemodynamic instability
- Basal IIEF-5 and doppler examination
- Blood count not within normal ranges
- No history of bleeding or coagulopathy
- No other serious medical illness
- Other investigational drug or device study
- Pudendal artery \< 1.5 mm and lesion lenght greater than 80 mm by visual estimation
- Pudendal restenosis from previous intervention
Key Trial Info
Start Date :
February 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04333173
Start Date
February 1 2017
End Date
January 1 2020
Last Update
April 3 2020
Active Locations (1)
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1
Centro Cuore
Novara, Italy