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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00396981 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
Intracranial Aneurysms |
Device: Matrix 2® coils for endovascular aneurysm occlusion Device: GDC® coils for endovascular aneurysm occlusion |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms |
Estimated Enrollment: | 630 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2015 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Matrix 2® Coils
|
Device: Matrix 2® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
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2: Active Comparator
GDC® Coils
|
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 neurologic death 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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Martha Conley | 510-440-7830 | Martha.Conley@bsci.com |
Contact: David Hess | 510-440-7749 | David.Hess@bsci.com |
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 |
Responsible Party: | Boston Scientific ( David Hess ) |
Study ID Numbers: | T4902, BSC0015 |
Study First Received: | November 6, 2006 |
Last Updated: | July 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00396981 History of Changes |
Health Authority: | United States: Institutional Review Board |
Intracranial saccular aneurysms Endovascular coiling therapy Retreatment Raymond scale |
Matrix GDC Guglielmi Detachable Coil |
Intracranial Aneurysm Aneurysm Vascular Diseases Central Nervous System Diseases |
Brain Diseases Cerebrovascular Disorders Intracranial Arterial Diseases |
Intracranial Aneurysm Aneurysm Nervous System Diseases Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Brain Diseases Cerebrovascular Disorders Intracranial Arterial Diseases |