At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms
In Brief
A Phase 4 clinical trial evaluating Matrix 2® coils for endovascular aneurysm occlusion and GDC® coils for endovascular aneurysm occlusion for Intracranial Aneurysms. Completed, enrolled 626 participants across 43 sites in 11 countries.
Detailed Summary
Primary Objectives: * To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. TAR is defined as clinically relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause. * To correlate defined angiographic endpoints with TAR rates and assess their predictive value, thereby providing a framework to establish clinically relevant endpoints for future studies. Secondary Objectives: * To evaluate device characteristics, incidence and severity of device-related adverse events, including death, neurological deterioration and changes in functional abilities. * To establish angiographic recurrence rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. * To explore an experimental, quantitative and volumetric endpoint and correlate these with existing qualitative assessments.
Study Details
Timeline
Interventions
endovascular aneurysm occlusion coil
endovascular aneurysm occlusion coil