Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

Emboflu

Status: Completed

Conditions: Cerebral Arteriovenous Malformations

Treatments: Device: SQUID™

Study type: Observational

Funder types: Industry

Identifiers

NCT02602990

SQUID

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

50 participants in 1 patient group

Cerebral AVM treated with SQUID™

Treatment:

Device: SQUID™