PRET: Patients Prone to Recurrence After Endovascular Treatment
NCT ID: NCT00626912
Last Updated: 2019-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
447 participants
INTERVENTIONAL
2007-06-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
platinum coils
endovascular coil embolization
standard endovascular coil embolization with or without adjunct techniques
2
hydrogel coils
endovascular coil embolization
standard endovascular coil embolization with or without adjunct techniques
Interventions
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endovascular coil embolization
standard endovascular coil embolization with or without adjunct techniques
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PRET-1: One ruptured or unruptured aneurysm, never treated, with a dimension ≥10mm (longest axis, including thrombosed portions of large or giant aneurysms); for ruptured lesions, patients should be in WFNS grade I, II or III.
* PRET-2: an Aneurysm presenting a major recurrence after previous coiling; and judged by the neurovascular team to require elective treatment.
* The anatomy of the lesion is such that endovascular treatment is possible with both types of coils (not necessarily certain or probable)
* The endovascular physician is content to use either type of coils (platinum or hydrogel-coated coils) but no other type of coils
* Patient is 18 or older
* Life expectancy is more than 2 years
Exclusion Criteria
* Patients with associated cerebral arteriovenous malformations
* When parent vessel occlusion, without simultaneous endosaccular coiling of the aneurysm, is the primary intent of the procedure
* Any absolute contraindication to endovascular treatment, angiography, or anaesthesia such as severe allergies to contrast or medications
18 Years
ALL
No
Sponsors
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Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Principal Investigators
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Jean RAYMOND, MD
Role: STUDY_CHAIR
Centre hospitalier de l'Université de Montréal (CHUM)
Daniel ROY, MD
Role: STUDY_DIRECTOR
Centre hospitalier de l'Université de Montréal (CHUM)
Locations
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Shands - University of Florida Hospital
Gainesville, Florida, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Mississipi Health Care
Jackson, Mississippi, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Washington University in St Louis
St Louis, Missouri, United States
University of Buffalo (SUNY)
Buffalo, New York, United States
Stony Brook University Medical Center (SUNY)
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The Methodist Hospital
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital
Montreal, Quebec, Canada
Instituto de Neurocirugía Dr. Asenjo
Santiago, , Chile
CHU Bordeaux - Hôpital Pellegrin
Bordeaux, , France
CHU Henri Mondor - Hôpital Henri Mondor
Créteil, , France
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, , France
CHU Nancy-Hôpital Central
Nancy, , France
CHU de Nantes - Hôpital Guillaume et René Laennec
Nantes, , France
Centre Hospitalier Sainte Anne
Paris, , France
Kobe City Medical Center General Hospital
Kobe, , Japan
Leeds General Infirmary
Leeds, , United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, , United Kingdom
Queens Medical Centre
Nottingham, , United Kingdom
Countries
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References
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Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2. No abstract available.
Other Identifiers
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ND07.001
Identifier Type: -
Identifier Source: org_study_id
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