Clinical Trial: Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

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

Detailed Summary:

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.


Sponsor: Emboflu

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Emboflu

Dates:
Date Received: November 6, 2015
Date Started: August 2015
Date Completion: April 2017
Last Updated: August 11, 2016
Last Verified: August 2016