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NCT00396981 · ClinicalTrials.gov registry record · Phase 4
MAPS Trial: Matrix And Platinum Science
A Phase 4 study, sponsored by Stryker Neurovascular.
- Completed
- Registry status
- Phase 4
- Development phase
- 626
- Enrollment target
NCT00396981 is a Phase 4 study that has completed, run by Stryker Neurovascular. The registered enrollment target is 626 participants.
The verdict
NCT00396981, a Phase 4 study, has completed, sponsored by Stryker Neurovascular.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 626 participants
- Enrollment target
Study 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, 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.
Interventions
- DEVICE Matrix 2® coils for endovascular aneurysm occlusion
- DEVICE GDC® coils for endovascular aneurysm occlusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 626 participants |
| Start Date | 2007-03 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00396981
The ClinicalTrials.gov registry entry for NCT00396981 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 626 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stryker Neurovascular, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matrix 2® coils for endovascular aneurysm occlusion is the first listed.
NCT00396981 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00396981 about?
NCT00396981 is a clinical study titled "MAPS Trial: Matrix And Platinum Science". 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 un...
What is the current status of trial NCT00396981?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 626 participants. The study started on 2007-03. Estimated completion is 2015-03.
What interventions are being tested in trial NCT00396981?
The interventions under investigation include: Matrix 2® coils for endovascular aneurysm occlusion (DEVICE), GDC® coils for endovascular aneurysm occlusion (DEVICE).
Who is sponsoring clinical trial NCT00396981?
This trial is sponsored by Stryker Neurovascular, which has 13 total clinical trials registered on ClinicalTrials.gov.
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