Clinical Trial: ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]

Official Title: ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae. A French, Observational, Prospective, Multicentric, Single Arm and Open Study

Brief Summary: The objective of this study is to evaluate the safety (at 1 month) and the performance (at 3-6 months) post last embolization with Onyx or Onyx associated with other embolization products (cyanoacrylate glue, coils, balloon, other…)

Detailed Summary:
Sponsor: Medtronic Neurovascular Clinical Affairs

Current Primary Outcome:

  • Evaluate the safety (at 1 month) post last embolization with Onyx or Onyx associated with other embolization products (cyanoacrylate glue, coils, balloon, other…) [ Time Frame: 1Month post procedure ]
    Number of related Adverse Events (AEs) 1 month post embolization only
  • Evaluate the performance (at 3-6 months) post last embolization with Onyx or Onyx associated with other embolization products (cyanoacrylate glue, coils, balloon, other…) [ Time Frame: Between 3 and 6 months post procedure ]
    • Healing at 3-6 months
    • Angio evaluation 3-6 month after last embolization
    • Patient clinical status (improved, stable, worsened) 3-6 months after embolization compared to the 1 month status


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 2013
Date Completion: July 2020
Last Updated: October 27, 2016
Last Verified: October 2016