Efficacy of Prostatic Arteries Embolization Using SQUIDPERI (SQUID-PAE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostate Hypertrophy(BPH)
• Intervention / Treatment: Device: Liquid embolic agent

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Touria EL AAMRI, Project manager; Phone Number: +33 (0)1 40 27 18 48; Email: touria.el-aamri@aphp.fr

Study Locations

• France
  • Marseille, France, 13385
    • Hôpital Timone (Radiologie adultes et neuroradiologie)
    • Contact: Vincent VIDAL; Phone Number: +33 (0) 4 13 42 90 60; Email: vincent.vidal@ap-hm.fr
  • Montpellier, France, 34295
    • Hôpital Arnaud de Villeneuve (Service Imagerie diagnostique et interventionnelle)
    • Contact: Hélène KOVACSIK; Phone Number: +33 (0) 4 67 33 60 00; Email: h-vernhet@chu-montpellier.fr
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou - AP-HP (Radiologie Interventionnelle vasculaire et oncologique)
    • Contact: Marc SAPOVAL; Phone Number: +33 (0) 1 56 09 37 40; Email: marc.sapoval2@aphp.fr
  • Strasbourg, France, 67000
    • Institut Cardiovasculaire de Strasbourg (ICS) - Clinique Rhena (Radiologie interventionnelle vasculaire et oncologique)
    • Contact: Gilles GOYAULT; Phone Number: +33 (0) 3 90 67 39 91; Email: g.goyault@ics.clinique-rhena.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Nonvulnerable men suffering from LUTS related to BPH and eligible to PAE.

Description

Inclusion Criteria:

• 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
• Good understanding of the French language

Exclusion Criteria:

• 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)
• Patient that already had a PAE
• Patient on AME (state medical aid)
• Participation in any interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Prostatic Artery Embolization	Device: Liquid embolic agent; Prostatic Artery Embolization using a non-adhesive liquid embolic agent composed of an EVOH (ethylene-vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide), with micronized tantalum powder suspended within it; Other Names: Squid Peri

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success at 3 months	Rate of clinical success defined as an IPSS <18 at follow-up with a decrease from baseline > 25% AND a quality of life (QoL, last question of IPSS questionnaire) < 4 at follow-up with a decrease from baseline ≥ 1.	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate technical success	Rate of immediate technical success. Immediate technical success is defined as an embolization of both lobes of the prostate using SQUID PERI.	Embolization procedure (baseline)
Clinical success at 6 months	Rate of clinical success defined as an IPSS <18 at follow-up with a decrease from baseline > 25% AND a quality of life (QoL, last question of IPSS questionnaire) < 4 at follow-up with a decrease from baseline ≥ 1.	Baseline and 6 months
Clinical success at 9 months	Rate of clinical success defined as an IPSS <18 at follow-up with a decrease from baseline > 25% AND a quality of life (QoL, last question of IPSS questionnaire) < 4 at follow-up with a decrease from baseline ≥ 1.	Baseline and 9 months
Clinical success at 12 months	Rate of clinical success defined as an IPSS <18 at follow-up with a decrease from baseline > 25% AND a quality of life (QoL, last question of IPSS questionnaire) < 4 at follow-up with a decrease from baseline ≥ 1.	Baseline and 12 months
IPSS at 3 months	Change in IPSS score and subscores compared to baseline.	Baseline and 3 months
IPSS at 6 months	Change in IPSS score and subscores compared to baseline.	Baseline and 6 months
IPSS at 9 months	Change in IPSS score and subscores compared to baseline.	Baseline and 9 months
IPSS at 12 months	Change in IPSS score and subscores compared to baseline.	Baseline and 12 months
QoL at 3 months	Change in QoL score (last question of IPSS questionnaire) compared to baseline.	Baseline and 3 months
QoL at 6 months	Change in QoL score (last question of IPSS questionnaire) compared to baseline.	Baseline and 6 months
QoL at 9 months	Change in QoL score (last question of IPSS questionnaire) compared to baseline.	Baseline and 9 months
QoL at 12 months	Change in QoL score (last question of IPSS questionnaire) compared to baseline.	Baseline and 12 months
IIEF-15 at 3 months	Change in IIEF-15 score and subscores compared to baseline.	Baseline and 3 months
IIEF-15 at 6 months	Change in IIEF-15 score and subscores compared to baseline.	Baseline and 6 months
IIEF-15 at 9 months	Change in IIEF-15 score and subscores compared to baseline.	Baseline and 9 months
IIEF-15 at 12 months	Change in IIEF-15 score and subscores compared to baseline.	Baseline and 12 months
Adverse events and serious adverse events	Number of adverse events and serious adverse events.	Up to 12 months
Benign prostatic hyperplasia medication at baseline	Number of benign prostatic hyperplasia medication.	Baseline
Benign prostatic hyperplasia medication at 3 months	Number of benign prostatic hyperplasia medication.	3 months
Re-intervention for benign prostatic hyperplasia at 12 months	Rate of re-intervention for benign prostatic hyperplasia (surgery, prostatic artery embolization).	Up to 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Balt International
• Investigators: Principal Investigator: Marc SAPOVAL, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: PAE; Prostatic Artery Embolization; SQUIDPERI; Liquid Embolic Agent
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: APHP250088; 2025-A00926-43 (Other Identifier: ANSM (French National Agency for the Safety of Medicines and Health Products))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: Two years after the last publication
• IPD Sharing Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No