Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02602990|
Recruitment Status : Active, not recruiting
First Posted : November 11, 2015
Last Update Posted : July 6, 2017
|Condition or disease||Intervention/treatment|
|Cerebral Arteriovenous Malformations||Device: SQUID™|
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 [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent|
|Actual Study Start Date :||August 2015|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||June 2018|
|Cerebral AVM treated with SQUID™||
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602990
|Leuven, Belgium, 3000|