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Trial record 50 of 320 for:    "Parkes Weber syndrome" OR "Vascular Malformations"

ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae (dAVF)

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ClinicalTrials.gov Identifier: NCT02180945
Recruitment Status : Completed
First Posted : July 3, 2014
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

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

Condition or disease
Arteriovenous Fistula

Study Type : Observational [Patient Registry]
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae. A French, Observational, Prospective, Multicentric, Single Arm and Open Study
Actual Study Start Date : July 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Group/Cohort
Intracranial Dural Arteriovenous Fistula
Adult patients requiring endovascular treatment of Intracranial Dural Arteriovenous Fistulae.



Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse event [ Time Frame: 3-6 months after procedure ]
    The number of adverse events (causing death or otherwise)

  2. Quality of life [ Time Frame: pre-procedure and at 3-6 months ]
    Describe EuroQoL quality of life survey results

  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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180945


Locations
France
Covidien
Paris, France
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
Principal Investigator: 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

Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02180945     History of Changes
Other Study ID Numbers: NV-ONY-001
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Keywords provided by Medtronic Neurovascular Clinical Affairs:
dAVF
Arteriovenous fistula
ONYX

Additional relevant MeSH terms:
Central Nervous System Vascular Malformations
Vascular Malformations
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Nervous System Malformations
Nervous System Diseases