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| Trial name | Patient population | Intervention | Comparison | Outcome |
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| Flow diversion in intracranial aneurysm treatment (FIAT) trial | Any patient with a “difficult” intracranial aneurysm in whom flow diversion is considered an appropriate if not the best yet unproved therapeutic option by the participating clinician | Flow diversion | Standard treatment of any of the following: (1) conservative management, (2) coil embolization with or without high porosity stent, (3) parent vessel occlusion, or (4) surgical clipping | Rate of successful therapy at 12 months.
Success defined as complete or near complete occlusion of the aneurysm combined with a modified Rankin score less than or equal to 2 |
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| LARGE aneurysm randomized trial: flow diversion versus traditional endovascular coiling therapy (LARGE) | Patients aged 21–75 internal carotid artery aneurysms (petrous, cavernous, and paraophthalmic) with neck and fundus morphologies amenable to either traditional endovascular treatments using coils or reconstruction with the flow diversion.
Aneurysm neck = or >4 mm.
Fundus = or >10 mm | Flow diversion | Endovascular coil embolization | Noninferiority with regard to efficacy and safety at 180 days after procedure.
Efficacy:
greater than 90% aneurysm occlusion rate and stable (or decreased) aneurysm size on cross-sectional CT or MRI.
Safety:
absence of major neurological event or death |
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| Endovascular treatment of intracranial aneurysm with pipeline versus coils with or without stents (EVIDENCE) trial | Unruptured saccular intracranial aneurysms larger than 7 mm | Pipeline embolization device | Endovascular coil embolization with or without balloon remodeling, with or without stent assistance | Angiographic aneurysm complete occlusion rates at 12 months |
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| Complete occlusion of coilable intracranial aneurysms (COCOA) trial | “Coilable” aneurysms of the petrous, cavernous, and supraclinoid segments of the internal carotid artery | Pipeline embolization device | Endovascular coil embolization | Complete angiographic occlusion of the target aneurysm 180 days after treatment |
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| Multicentre randomised trial on selective endovascular aneurysm occlusion with coils versus parent vessel reconstruction using the SILK flow diverter (MARCO POLO) | Patients with at least one documented untreated, unruptured intracranial aneurysm suitable for occlusion with an intracranial device | SILK flow diverter without coils | Endovascular coil embolization with or without balloon remodeling or stent assistance | Angiographic aneurysm complete occlusion rates at 12 months |
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| The Surpass intracranial aneurysm embolization system pivotal trial to treat large or giant wide neck aneurysms (SCENT trial) | 19–80-year-old patients with single targeted wide neck, large, or giant intracranial aneurysms of the internal carotid artery up to the terminus | Surpass flow diverter | None | Complete aneurysm occlusion without clinically significant stenosis (>50%) of parent artery at 12 months.
Absence of neurological death or ipsilateral stroke at 12 months |
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| International subarachnoid aneurysm trial II (ISAT II) | Ruptured intracranial aneurysms not included in the original ISAT study:
at least one documented, intradural, and intracranial aneurysm ruptured within last 30 days.
Subarachnoid hemorrhage, world federation of neurological surgery grade 4 or less.
The patient and aneurysm are considered appropriate for either surgical or endovascular treatment by the treating team | Endovascular therapy with use of coils, balloon remodeling, stents, or flow diverters as per physician performing treatment | Surgical management, surgical clipping with or without bypass, and other surgical flow redirecting methods as per physician performing treatment | Poor clinical outcomes; modified Rankin scale >2 at 12 months |
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