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OpenTrials
Completed

NCT Number: NCT02180958

Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs

To assess safety and efficacy of ONYX treatment for cAVM:

Completed

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Key information

Conditions

Cerebral Arteriovenous Malformations Arteriovenous Malformations Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Vascular Malformations Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Intracranial Arterial Diseases Intracranial Arteriovenous Malformations Nervous System Diseases Nervous System Malformations Vascular Diseases Vascular Malformations

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Besançon, Besançon, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient presents a cerebral AVM (not already treated) that can be treated by embolization with Onyx whether or not associated with a cyanoacrylate based adhesive,
  • The patient is at least 6 years old.

Exclusion criteria

  • During the treatment period for his/her cerebral AVM, the patient participates in a study assessing another medical device, another procedure or a drug.
  • The patient and/or his/her legal representative (if applicable) refuses to give his/her consent to the collection and processing of data required by the centralized follow-up. For patients who refused collection of their personal data, only, the reason for non inclusion and date of implantation will be documented.
  • Any condition that could prevent follow-up of the patient.

Treatment and study plan

Primary outcomes

  1. Incidence of Device or procedure Adverse Events

    Time frame: 1 month

    Device or procedure related adverse events

  2. Healing rate

    Time frame: 12 or 36 months

    No residual early venous return

    • 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.

Secondary outcomes

  1. Describe funtional independence

    Time frame: 1 and 12 months

    Describe mRS scores assessed by a certified physician

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Official study title

Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs. Prospective, Multi-center and Observational French Study

Acronym: cAVM

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jul 3, 2014
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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