Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

Completed

• Conditions: Cerebral Arteriovenous Malformations
• Interventions: Device: SQUID™

• Registration Number: NCT02602990
• Lead Sponsor: Emboflu

Brief Summary

A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.

Detailed Description

This observational study will collect data about the treatment of ruptured, unruptured, untreated or endovascular previously treated AVM's.

Primary endpoint is safety. Safety will be assessed with the number of procedure-related complications occurring during the endovascular treatment until 30 days after the final embolization.

Secondary endpoint is efficacy. Efficacy will be assessed by angiography and clinical outcome assessments (mRS).

For each patient enrolled, data will be collected at inclusion, at each embolization session and at 6 ± 1 months after the end of the endovascular treatment phase.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patient must sign the informed consent form prior to the index-procedure. If patient is unable to provide it him- or herself because of the patient's medical condition, the informed consent of the patient's legally authorized representative shall be requested.
2. The patient has an untreated or endovascular previously treated cerebral AVM for which endovascular treatment is indicated.
3. The patient is at least 18 years old.

Exclusion Criteria

1. Patient is pregnant.
2. Patient with renal insufficiency (GFR < 45 ml/min/1.73 m²)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cerebral AVM treated with SQUID™	SQUID™	-

Primary Outcome Measures

Name	Time	Method
Incidence of complications / adverse events (Safety)	From the start of the procedure until 30 days after procedure	The safety is assessed with the number of procedure-related complications occurring during endovascular treatment until 30 days after the final embolization session. Procedure-related complications include complications/adverse events related to the procedure or to the device such as but not limited to hemorrhagic and ischemic complications.

Secondary Outcome Measures

Name	Time	Method
Clinical outcome measurement with mRS (Efficacy)	At 6 months after the last treatment session, compared to baseline	Change of mRS score at 6 months after treatment phase is assessed compared to baseline mRS score.
Degree of targeted portion of AVM occlusion	6 months	The degree of the predefined targeted portion of the AVM's occlusion will be assessed angiographically.

Trial Locations

Locations (6)

AZ Sint-Lucas; 🇧🇪 Gent, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Belgium

Ziekenhuis Oost Limburg (ZOL); 🇧🇪 Genk, Belgium

Alfried Krupp Krankenhaus; 🇩🇪 Essen, Germany

UZ Leuven; 🇧🇪 Leuven, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium