Clinical Trial: ONYX Evaluation in the Endovascular Treatment of Cerebral Arteriovenous Malformations (cAVM)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: Assessment of ONYX in Endovascular Cerebral AVM. Prospective, Multi-centre and Observational French Study.
Brief Summary:
The main objective of this study is to assess the safety at 1 month after any embolization session and the efficacy at:
- 12 months post last embolization in case of treatment with embolization only
- 12 months after additional treatment with neurosurgery
- 36 months after additional treatment with radiosurgery
Detailed Summary:
Sponsor: Medtronic Neurovascular Clinical Affairs
Current Primary Outcome:
- To assess safety [ Time Frame: At 1 month after embolization ]Evaluation of the number of events, related to the device or the procedure.
- To assess the performance (healing) [ Time Frame: At 12 or 36 months after embolization ]
Evaluation of healing rate at:
- 12 months after last embolization in case of complete treatment or stopping treatment;
- 12 months after additional intervention in case of additional treatment required by neuro-surgery;
- 36 months after additional intervention in case of additional treatment required by radio-surgery.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medtronic Neurovascular Clinical Affairs
Dates:
Date Received: April 25, 2014
Date Started: July 2014
Date Completion: September 2019
Last Updated: October 27, 2016
Last Verified: October 2016