MAPS Trial: Matrix And Platinum Science (MAPS)
- 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.
- 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.
|Intracranial Aneurysms||Device: Matrix 2® coils for endovascular aneurysm occlusion Device: GDC® coils for endovascular aneurysm occlusion||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms|
- 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 [ Time Frame: Reintervention or 12 months ]Number of participants with angiographic assessment of "complete obliteration".
- Neurological Assessments [ Time Frame: 12 months ]The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects "same or better".
- 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 ]
|Study Start Date:||March 2007|
|Study Completion Date:||March 2015|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Matrix 2® Coils
Matrix 2® Coils for endovascular aneurysm occlusion
Device: Matrix 2® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
Active Comparator: GDC® Coils
GDC® Coils for endovascular aneurysm occlusion
Device: GDC® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396981
Show 43 Study Locations
|Principal Investigator:||S. Claiborne Johnston, MD, PhD||University of California, San Francisco, CA|
|Principal Investigator:||Cameron McDougall, MD||Barrow Neurological Institute, Phoenix, AZ|
|Principal Investigator:||Anil Gholkar, MD||Newcastle Upon Tyne Hospitals, NHS Trust, UK|