International Subarachnoid Aneurysm Trial II (ISAT II)
Intracranial Hemorrhage Ruptured Aneurysm
About this trial
This is an interventional treatment trial for Intracranial Hemorrhage Ruptured Aneurysm focused on measuring Aneurysm, Intracranial Aneurysm, Vascular Diseases, Cardiovascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with absolute contraindications administration of contrast material (any type)
- Patients with AVM-associated aneurysms
- Aneurysm located at basilar apex
Sites / Locations
- Montefiore Medical CenterRecruiting
- Foothills Medical Centre
- University of Alberta HospitalRecruiting
- Centre Hospitalier de l'Université de Montréal - Hôpital Notre DameRecruiting
- Vall d'Hebron HospitalRecruiting
- University of ValladolidRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Endovascular management
Surgical 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.
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.