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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
626
endovascular aneurysm occlusion coil
endovascular aneurysm occlusion coil
St. Joseph's Hospital Barrow Neurological Institute
Phoenix, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Rush Presbyterian
Chicago, Illinois, United States
The Universtiy of Iowa
Iowa City, Iowa, United States
Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.
Time frame: 12 months
Angiographic Assessments
Number of participants with angiographic assessment of "complete obliteration".
Time frame: Reintervention or 12 months
Neurological Assessments
The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects "same or better".
Time frame: 12 months
Technical Procedure Success
Time frame: Post-procedure
Target Aneurysm Recurrence
Time frame: 2 years
Target Aneurysm Recurrence
Time frame: 3 years
Target Aneurysm Recurrence
Time frame: 5 years
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University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Massachusetts Worcester
Worcester, Massachusetts, United States
Providence Detroit
Southfield, Michigan, United States
St. Joseph's Hospital
Saint Paul, Minnesota, United States
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