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Completed

NCT Number: NCT02180945

ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae

The objective of this study is to evaluate the safety and performance post last embolization with Onyx

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Key information

Conditions

Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Covidien

Paris, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Neurological clinical evolution

    Time frame: 1Month post procedure

    Improved, Stable, Worsened, death

  2. Healing rate

    Time frame: 3-6 months post procedure

    Number of patients with No residual early venous return

Secondary outcomes

  1. Adverse event

    Time frame: 3-6 months after procedure

    The number of adverse events (causing death or otherwise)

  2. Quality of life EQ-5D

    Time frame: pre-procedure and at 3-6 months

    Health State Score increase

  3. Describe functional independence

    Time frame: 1 and 12 months after procedure

    Describe mRS scores assessed by a certified physician

  4. Technical performance of the product

    Time frame: 12 months after procedure

    Volume injected per embolization session

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Official study title

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

Acronym: dAVF

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 3, 2014
Registry last updated
Jan 28, 2019

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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