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Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment. (ARETA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by CHU de Reims
Sponsor:
Information provided by (Responsible Party):
CHU de Reims
ClinicalTrials.gov Identifier:
NCT01942512
First received: September 11, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

Endovascular treatment is now the first line treatment for the management of intracranial aneurysms. However aneurysm recanalization is an important limitation to this treatment. Several factors seems to be associated with aneurysm recanalization including medical history of the patient, aneurysm status (ruptured or unruptured), aneurysm size and location, modalities of treatment, immediate post-operative occlusion of the aneurysm.

A precise knowledge of factors increasing the risk of aneurysm recanalization is quite important to optimize strategy of treatment and reduce the recanalization rate. No large, prospective, multicenter trial dealing with this question has been published in the literature.


Condition Intervention
Intracranial Aneurysm
Device: Endovascular treatment of intracranial aneurysm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Risk Factors Associated With Intracranial Aneurysm Recanalization After Endovascular Treatment

Resource links provided by NLM:


Further study details as provided by CHU de Reims:

Primary Outcome Measures:
  • aneurysm recanalization [ Time Frame: assessed at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1275
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ARETA
All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment
Device: Endovascular treatment of intracranial aneurysm

Detailed Description:

The prevalence of intracranial aneurysms is high (between 2 and 3%). The major risk of an intracranial aneurysm is its rupture leading to intracranial bleeding (subarachnoid, parenchymal and/or intraventricular) associated with mortality and morbidity.

Endovascular treatment is now the first line treatment for both ruptured and unruptured aneurysms. One major limitation of this treatment is aneurysm recanalization observed in approximately 20% of aneurysms and leading to retreatment in approximately 10% of aneurysms.

CARAT trial has shown that the risk of rebleeding after aneurysm coiling is significantly associated with the quality of aneurysm occlusion. The risk of rebleeding is 1.1% in case of complete occlusion, 2.9% when aneurysm occlusion is between 91 and 99%, 5.9% when aneurysm occlusion is between 70 et 90%, and 17.6% when aneurysm occlusion is less than 70%. However it should be outlined that few studies have clearly analyzed the relation between recanalization and rebleeding.

Several factors are probably associated with aneurysm recanalization. Ruptured aneurysms are more prone to aneurysm recanalization than unruptured aneurysm. Age, elevated blood pressure, smoking probably play a role in aneurysm recanalization. Anatomical features are also probably key factors for aneurysm recanalization. Aneurysm and neck sizes are probably important factors for aneurysm recanalization. The role of aneurysm location is more controversial. Therapeutic factors certainly play also an important role, but precise analyses are still missing. The quality of post-operative aneurysm occlusion is probably important for the future evolution of the aneurysm. Surface-modified coils have not demonstrated any efficacy to prevent aneurysm recanalization. The role of adjunctive techniques has also not precisely be evaluated (remodeling, stenting).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment

Criteria

Inclusion Criteria:

  • Patients treated by endovascular approach for intracranial aneurysm(s)
  • Patients older than 18 years
  • Patients accepting to participate to the study

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients protected by law
  • Patients already treated by endovascular approach for an intracranial aneurysm
  • Patients having a brain arteriovenous malformation
  • Patients having a fusiform aneurysm
  • Patients having a dissecting aneurysm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942512

Contacts
Contact: Laurent PIEROT, PhD, MD 326788734 ext 33 lpierot@chu-reims.fr
Contact: Gwendoline ARNOULT 3326789267 ext 33 garnoult@chu-reims.fr

Locations
France
CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33404
Principal Investigator: Xavier BARREAU, MD         
CHU de CAEN Not yet recruiting
Caen, France, 14000
Principal Investigator: Patrick COURTHEOUX, PhD, MD         
CHU de Clermont-Ferrand Not yet recruiting
Clermont-ferrand, France, 63000
Principal Investigator: Beatrix JEAN, MD         
AP-HP, Hôpital Beaujon Not yet recruiting
Clichy, France, 92110
Principal Investigator: Laurent SPELLE, Ph, MD         
AP-HP, Hôpital Henri Mondor Not yet recruiting
Creteil, France, 94000
Principal Investigator: Sophie GALLAS, MD         
CHU de Dijon Not yet recruiting
Dijon, France, 21079
Principal Investigator: Frédéric RICOLFI, PhD, MD         
CHRU de LILLE Not yet recruiting
Lille, France, 59037
Principal Investigator: Erwah KALSOUM, MD         
Hospices Civils de Lyon Not yet recruiting
Lyon, France, 69002
Principal Investigator: Francis TURJMAN, PhD, MD         
CHU de MONTPELLIER Not yet recruiting
Montpellier, France, 34295
Principal Investigator: Alain BONAFE, PhD, MD         
CHU de Nancy Not yet recruiting
Nancy, France, 54035
Principal Investigator: Serge BRACARD, PhD, MD         
CHU de Nantes Not yet recruiting
Nantes, France, 44093
Principal Investigator: Hubert DESAL, PhD, MD         
CHU de Nice Not yet recruiting
Nice, France, 06003
Principal Investigator: Jacques SEDAT, MD         
Centre Hospitalier Sainte-Anne Not yet recruiting
Paris, France, 75014
Principal Investigator: Denis TRYSTRAM, MD         
Centre Hospitalier Universitaire de Reims Not yet recruiting
Reims, France, 51092
Contact: Laurent PIEROT, PhD, MD    3326788764 ext 33    lpierot@chu-reims.fr   
Contact: Gwendoline ARNOULT    3326789267 ext 33    garnoult@chu-reims.fr   
Principal Investigator: Laurent PIEROT, PhD, MD         
CHU de Rennes Not yet recruiting
Rennes, France, 35033
Principal Investigator: Jean-Yves GAUVRIT, PhD, MD         
CHU de Saint-Etienne Not yet recruiting
Saint-etienne, France, 42055
Principal Investigator: Mohammed AGGOUR, MD         
Hopital Foch Not yet recruiting
Suresnes, France, 92151
Principal Investigator: Georges RODESCH, MD         
CHU de Toulouse Not yet recruiting
Toulouse, France, 31059
Principal Investigator: Christophe COGNARD, Ph, MD         
CHU de Tours Not yet recruiting
Tours, France, 37044
Principal Investigator: Denis HERBRETEAU, PhD, MD         
Sponsors and Collaborators
CHU de Reims
  More Information

No publications provided

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT01942512     History of Changes
Other Study ID Numbers: PN12145
Study First Received: September 11, 2013
Last Updated: September 11, 2013
Health Authority: France: Ministry of Health

Keywords provided by CHU de Reims:
Intracranial Aneurysm - Endovascular treatment -
Coiling - Stenting - Flow diversion - Flow disruption -
Recanalization - Risk factors

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014