Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396981
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2006-11-06
Brief Title:
MAPS Trial Matrix And Platinum Science
Sponsor:
Stryker Neurovascular
Organization:
Stryker Neurovascular
Study Overview
Official Title:
A Prospective Randomized Multicenter Trial Investigating Matrix 2 and GDC Detachable Coils for the Treatment of Intracranial Saccular Aneurysms
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAPS
Brief Summary:
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 rupturere-rupture andor 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
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 rupturere-rupture andor 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
Detailed Description:
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 rupturere-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 rupturere-rupture andor 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
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 rupturere-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 rupturere-rupture andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BSC0015 | OTHER | Stryker Neurovascular | None |