About this trial
Prostatic Artery Embolization (PAE) is a recognized mini-invasive treatment of bothersome Lower Urinary Tract Symptoms (LUTS) related to Benign Prostatic Hyperplasia (BPH). Particle embolics are used almost exclusively for embolization, with wide variation in the type and size of particles showing similar performance and safety results. Even if its durability relies on multiple risk factors, LUTS recurrence-free survival probability decreases with years. It is demonstrated that recanalization of the native prostatic artery is found in 66% of patients experiencing LUTS recurrence. Artery recanalization after several months has been reported in embolization with microparticles. The investigators addressed this issue using the liquid embolic agent SQUIDPERI in a prospective cohort of patients undergoing rePAE and showed a good clinical success rate (76.7%) at 3 months. Since then, the investigators perform initial PAE using SQUIDPERI with good results.
The aim of SQUID-PAE study is to assess the efficacy of PAE using SQUIDPERI in an initial PAE setting in a multicenter prospective study.
Eligibility criteria
Qualifiers
Age ≥18 years
Patient scheduled for a PAE using SquidPERI as part of routine care
Patient informed who signed the informed consent form
French social security affiliation
Disqualifiers
Patient unwilling or unlikely to comply with FU schedule
Known severe allergy to iodine
Known severe hepatic impairment
Vulnerable patient populations (such as patient under guardianship, curatorship, deprived of liberty)
Trial design
Treatments tested in this trial
- Liquid embolic agent
Treatment groups
Sponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Balt International
Collaborator