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International Subarachnoid Aneurysm Trial II
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Summary
The purpose of this study is to compare the clinical outcome of surgical clipping and endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT Study.
Official title: International Subarachnoid Aneurysm Trial II Comparing Clinical Outcomes of Surgical Clipping and Endovascular Coiling for Ruptured Intracranial Aneurysms Not Included in the Original ISAT Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1724
Start Date
2012-11-12
Completion Date
2024-12
Last Updated
2024-08-15
Healthy Volunteers
No
Interventions
surgical management
Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.
Endovascular management
Endovascular treatment will also be performed as soon as possible following randomization,according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.
Locations (6)
Montefiore Medical Center
The Bronx, New York, United States
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Montreal, Quebec, Canada
Vall d'Hebron Hospital
Barcelona, Spain
University of Valladolid
Valladolid, Spain