Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

September 19, 2019 updated by: Emboflu
A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Genk, Belgium, 3600
        • Ziekenhuis Oost Limburg (ZOL)
      • Gent, Belgium, 9000
        • AZ Sint-Lucas
      • Kortrijk, Belgium, 8500
        • Az Groeninge
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Germany
      • Essen, Germany, 45131
        • Alfried Krupp Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a cerebral AVM for whom endovascular treatment is indicated.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cerebral AVM treated with SQUID™
Device: SQUID™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the start of the procedure until 30 days after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 6 months after the last treatment session, compared to baseline
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emboflu

Collaborators

Archer Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQUID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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