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MAPS Trial: Matrix And Platinum Science

NCT00396981 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 626

Last updated 2016-02-17

Study results available
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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.

Conditions

  • Intracranial Aneurysms

Interventions

DEVICE

Matrix 2® coils for endovascular aneurysm occlusion

endovascular aneurysm occlusion coil

DEVICE

GDC® coils for endovascular aneurysm occlusion

endovascular aneurysm occlusion coil

Sponsors & Collaborators

  • Stryker Neurovascular

    lead INDUSTRY

Principal Investigators

  • S. Claiborne Johnston, MD, PhD · University of California, San Francisco, CA

  • Cameron McDougall, MD · Barrow Neurological Institute, Phoenix, AZ

  • Anil Gholkar, MD · Newcastle Upon Tyne Hospitals, NHS Trust, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-01-31
Completion
2015-03-31

Countries

  • United States
  • Australia
  • Canada
  • China
  • France
  • Germany
  • Mexico
  • Norway
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00396981 on ClinicalTrials.gov