ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae

NCT02180945 | Completed DMC

• 1 other identifier: NV-ONY-001
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arteriovenous Fistula

Keywords

dAVF; Arteriovenous fistula; ONYX

Outcome Measures

Primary Outcomes (2)

• Neurological clinical evolution

  Improved, Stable, Worsened, death

  1Month post procedure

• Healing rate

  Number of patients with No residual early venous return

  3-6 months post procedure

Secondary Outcomes (4)

• Adverse event

  3-6 months after procedure

• Quality of life EQ-5D

  pre-procedure and at 3-6 months

• Describe functional independence

  1 and 12 months after procedure

• Technical performance of the product

  12 months after procedure

Study Arms (1)

Intracranial Dural Arteriovenous Fistula

Adult patients requiring endovascular treatment of Intracranial Dural Arteriovenous Fistulae.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients presenting at the participating centers for whom an intracranial dAVF (not previosly treated) needs to be treated (unrelated to the planned treatment) and who agree to the collection and transmission of related data.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (1)

Covidien

Paris, France

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

• Christophe Cognard, Prof. Dr.

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

• Frédéric Ricolfi, Prof. Dr.

  Centre Hospitalier Universitaire Dijon

  PRINCIPAL INVESTIGATOR

• Patrick Courthéoux, Prof. Dr.

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

• Laurent Spelle, Prof. Dr.

  Hôpital Beaujon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: July 3, 2014
• Study Start: July 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

FR (1)