Intracranial Aneurysms Clinical Trial
Official title:
A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms
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.
The endovascular treatment of intracranial aneurysms has become an accepted alternative to
surgical repair given the many recent advances with neurointerventional devices and
procedures. The introduction of GDC coils in 1993 provided physicians and their patients a
less invasive treatment option. Additionally, the results of two large international trials,
ISAT and ISUIA, have shown the benefits of endovascular treatment over surgery for treatment
of specific types of aneurysms. One limitation of endovascular coil embolization is aneurysm
recurrence or recanalization which is not infrequently observed angiographically at follow
up. Aneurysm recanalization may be a result of aneurysm morphology, anatomic location and
flow orientation, aneurysm regrowth or the degree of coil compaction. Despite the widespread
adoption of endovascular aneurysm coiling, there remains much to be learned about the
efficacy and optimization of this treatment modality.
The goal of endovascular embolization of intracranial aneurysms is to prevent rupture or
re-rupture. Fortunately, the incidence of aneurysm rupture following coil embolization is
very low. Follow-up angiographic analysis to evaluate the occlusion and stability of the
treated aneurysm provides a surrogate endpoint against which to weigh the likelihood of
rupture/re-rupture. However, angiographic interpretation is subjective, operator dependent
and can be influenced by multiple confounding variables.
The MAPS trial will examine Target Aneurysm Recurrence Rates: clinically relevant recurrence
rates resulting in target aneurysm reintervention, rupture/re-rupture and/or death from an
unknown cause for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular
aneurysms. The trial will compare TAR rates to recurrences measured by angiographic analysis
and assess the utility of angiographic analysis for predicting clinically relevant
recurrences.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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