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