Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

Last updated: September 19, 2019
Sponsor: Emboflu
Overall Status: Completed

Phase

N/A

Condition

Cerebral Arteriovenous Malformations

Holoprosencephaly

Hemangioma

Treatment

N/A

Clinical Study ID

NCT02602990
SQUID
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient must sign the informed consent form prior to the index-procedure. If patientis 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 berequested.

  2. The patient has an untreated or endovascular previously treated cerebral AVM for whichendovascular treatment is indicated.

  3. The patient is at least 18 years old.

Exclusion

Exclusion Criteria:

  1. Patient is pregnant.

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

Study Design

Total Participants: 50
Study Start date:
August 01, 2015
Estimated Completion Date:
May 31, 2019

Study 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.

Connect with a study center

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • Ziekenhuis Oost Limburg (ZOL)

    Genk, 3600
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Gent, 9000
    Belgium

    Site Not Available

  • AZ Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Alfried Krupp Krankenhaus

    Essen, 45131
    Germany

    Site Not Available

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