Overview

This trial is active, not recruiting.

Condition arteriovenous fistula
Sponsor Medtronic Neurovascular Clinical Affairs
Start date July 2013
End date January 2020
Trial size 110 participants
Trial identifier NCT02180945, NV-ONY-001

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…)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Adult patients requiring endovascular treatment of Intracranial Dural Arteriovenous Fistulae.

Primary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - The patient has an intracranial dAVF which could be treated by ONYX embolization, whether or not associated to other embolization products. - The patient is at least 18 years of age. Exclusion Criteria: - The patient needs to be treated for the dAVF with another treatment option (for example by surgery) than embolization within a period of less than 6 months (to be counted as from the first treatment) - The patient participates to another clinical study during the treatment period for his/her dAVF, evaluating another medical devices, procedure or medication. - The patient refuses to give consent to the collection and processing of data required for centralized monitoring. - A condition which could jeopardize follow-up of the patient.

Additional Information

Official title ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae. A French, Observational, Prospective, Multicentric, Single Arm and Open Study
Principal investigator Christophe Cognard, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Neurovascular Clinical Affairs.