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.

Status: Active_not_recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients at least 18 years of age

• At least one documented, intradural, intracranial aneurysm, ruptured within last 30 days

• SAH WFNS grade 4 or less

• The patient and aneurysm are considered appropriate for either surgical or endovascular treatment by the treating team

Locations
United States
New York
Montefiore Medical Center
Bronx
Other Locations
Canada
Foothills Medical Centre
Calgary
University of Alberta Hospital
Edmonton
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Montreal
Spain
Vall d'Hebron Hospital
Barcelona
University of Valladolid
Valladolid
Time Frame
Start Date: 2012-11-12
Completion Date: 2024-12
Participants
Target number of participants: 1724
Treatments
Active_comparator: Endovascular management
Endovascular treatment will 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.
Active_comparator: 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.
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov

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