MAPS Trial: Matrix And Platinum Science

Completed · Phase 4

Conditions studied: Intracranial Aneurysms

In brief

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.

Key facts

Study ID

NCT00396981

Run by

Stryker Neurovascular

People needed

626

Starts

2007-03-01

Expected to finish

2015-03-01

Last updated by the study team

2016-02-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is between 18 and 80 years of age (inclusive).
• Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils.
• Both GDC® Coils and Matrix 2® Coils (Every attempt should be made to treat with as much randomized coil type as possible to achieve optimal occlusion.) are treatment options (all shapes allowed with exception of GDC VortX Coil).
• Target aneurysm can be adequately coiled at index procedure (NO staged coiling procedures). If a Neuroform stent is to be placed during a separate preliminary procedure, then screening and enrollment for the coiling procedure must take place after the stenting procedure is completed.
• Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician.
• Patient (or patient's legally authorized representative for centers in the United States) has provided written informed consent.
• Patient is willing and able to comply with protocol follow-up requirements.

You may not qualify if…

• Patient is < 18 or > 80 years old.
• Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting).
• Target aneurysm is > 20 mm maximum luminal dimension, < 4 mm maximum luminal dimension.
• Target aneurysm has been previously treated by surgery or endovascular therapy.
• Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.
• Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm.
• Patient presents with Modified Rankin Score 4 or 5 at baseline.
• Patient is concurrently enrolled in another investigational drug or device study unless permission is granted by the sponsor.
• Patient has known hypersensitivity to Polyglycolic Polylactic Acid (PGLA), platinum, nickel, stainless steel or structurally related compounds found in Matrix 2® Coils and/or GDC® Coils.
• Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure.
• Patients who are unable to complete scheduled follow up assessments at the enrolling center due to limited life expectancy (< 12 months), comorbidities or geographical considerations.
• Planned use of adjunctive therapy stents except Neuroform is not allowed.
• Patients with Moya-Moya disease, AVMs, AV fistula, intracranial tumors, intracranial hematoma (unrelated to target aneurysm), significant atherosclerotic stenosis, tortuousity or other conditions preventing access to the target aneurysm.
• Patients with multiple aneurysms.
• Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion of the investigator.
• Female patient has a positive pregnancy assessment at baseline.

Where it is running

• St. Joseph's Hospital Barrow Neurological Institute — Phoenix, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• Yale-New Haven Hospital — New Haven, Connecticut, United States
• Rush Presbyterian — Chicago, Illinois, United States
• The Universtiy of Iowa — Iowa City, Iowa, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Massachusetts Worcester — Worcester, Massachusetts, United States
• Providence Detroit — Southfield, Michigan, United States
• St. Joseph's Hospital — Saint Paul, Minnesota, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Barnes Jewish Mallinckrodt Institute of Radiology — St Louis, Missouri, United States
• Sunrise Hospital and Medical Center — Las Vegas, Nevada, United States
• University of New Mexico Department of Neurosurgery — Albuquerque, New Mexico, United States
• Stony Brook Medical Center — Stony Brook, New York, United States
• Carolina Neurosurgery & Spine Associates, PA — Charlotte, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Mercy Health Center — Oklahoma City, Oklahoma, United States
• OHSU — Portland, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Fort Sanders Regional Medical Center — Knoxville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Methodist Hospital — Houston, Texas, United States
• University of Washington Harborview Medical Center — Seattle, Washington, United States
• Sacred Heart Providence — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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