NCT02602990

Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Emboflu · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cerebral Arteriovenous Malformations

Interventions

Type	Name	Description
DEVICE	SQUID™

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2015-11-11
• Last updated: 2019-09-20

Locations

6 sites across 2 countries: Belgium, Germany