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Completed

NCT Number: NCT02602990

Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

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

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Key information

Conditions

Cerebral Arteriovenous Malformations Arteriovenous Malformations Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Vascular Malformations Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Intracranial Arterial Diseases Intracranial Arteriovenous Malformations Nervous System Diseases Nervous System Malformations Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Antwerpen, Edegem, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • The patient has an untreated or endovascular previously treated cerebral AVM for which endovascular treatment is indicated.
  • The patient is at least 18 years old.

Exclusion criteria

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

Treatment and study plan

SQUID™

Device

Primary outcomes

  1. Incidence of complications / adverse events (Safety)

    Time frame: 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 outcomes

  1. Clinical outcome measurement with mRS (Efficacy)

    Time frame: 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.

  2. Degree of targeted portion of AVM occlusion

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Emboflu

Industry

Collaborators

  • Archer Research

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 11, 2015
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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