Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

Emboflu50 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Cerebral Arteriovenous Malformations

Interventions

SQUID™DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (6)

UZ Antwerpen

Edegem, Belgium

Ziekenhuis Oost Limburg (ZOL)

Genk, Belgium

AZ Sint-Lucas

Ghent, Belgium

AZ Groeninge

Kortrijk, Belgium

UZ Leuven

Outcomes

Primary Outcomes

Incidence of complications / adverse events (Safety)

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.

Time frame: From the start of the procedure until 30 days after procedure

Secondary Outcomes

Clinical outcome measurement with mRS (Efficacy)

Change of mRS score at 6 months after treatment phase is assessed compared to baseline mRS score.

Time frame: At 6 months after the last treatment session, compared to baseline

Degree of targeted portion of AVM occlusion

The degree of the predefined targeted portion of the AVM's occlusion will be assessed angiographically.

Time frame: 6 months

Data from ClinicalTrials.gov

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