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| Sponsor: | Stryker Neurovascular |
|---|---|
| Information provided by (Responsible Party): | Stryker Neurovascular |
| ClinicalTrials.gov Identifier: | NCT00396981 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 |
| Enrollment: | 626 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2015 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Matrix 2® Coils
|
Device: Matrix 2® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
|
|
Active Comparator: 2
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 42 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 |
More Information
| Responsible Party: | Stryker Neurovascular |
| ClinicalTrials.gov Identifier: | NCT00396981 History of Changes |
| Other Study ID Numbers: | T4902, BSC0015 |
| Study First Received: | November 6, 2006 |
| Last Updated: | November 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Intracranial saccular aneurysms Endovascular coiling therapy Retreatment Raymond scale |
Matrix GDC Guglielmi Detachable Coil |
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |