MAPS Trial: Matrix And Platinum Science

NCT00396981 | Completed Phase 4 Results DMC

• 2 other identifiers: T4902BSC0015
• Study Type: interventional
• Target: 626
• Locations: 11 countries
• Sites: 43

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, 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

Keywords

Intracranial saccular aneurysms; Endovascular coiling therapy; Retreatment; Raymond scale; Matrix; GDC; Guglielmi Detachable Coil

Outcome Measures

Primary Outcomes (1)

• Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.

  12 months

Secondary Outcomes (6)

• Angiographic Assessments

  Reintervention or 12 months

• Neurological Assessments

  12 months

• Technical Procedure Success

  Post-procedure

• Target Aneurysm Recurrence

  2 years

• Target Aneurysm Recurrence

  3 years

Study Arms (2)

Matrix 2® Coils

ACTIVE COMPARATOR

Matrix 2® Coils for endovascular aneurysm occlusion

Device: Matrix 2® coils for endovascular aneurysm occlusion

GDC® Coils

ACTIVE COMPARATOR

GDC® Coils for endovascular aneurysm occlusion

Device: GDC® coils for endovascular aneurysm occlusion

Interventions

Matrix 2® coils for endovascular aneurysm occlusion DEVICE

endovascular aneurysm occlusion coil

Matrix 2® Coils

GDC® coils for endovascular aneurysm occlusion DEVICE

endovascular aneurysm occlusion coil

GDC® Coils

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (43)

St. Joseph's Hospital Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Rush Presbyterian

Chicago, Illinois, 60640, United States

Location

The Universtiy of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Massachusetts Worcester

Worcester, Massachusetts, 01655, United States

Location

Providence Detroit

Southfield, Michigan, 48075, United States

Location

St. Joseph's Hospital

Saint Paul, Minnesota, 55104, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Barnes Jewish Mallinckrodt Institute of Radiology

St Louis, Missouri, 63110, United States

Location

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

Location

University of New Mexico Department of Neurosurgery

Albuquerque, New Mexico, 87131, United States

Location

Stony Brook Medical Center

Stony Brook, New York, 11794, United States

Location

Carolina Neurosurgery & Spine Associates, PA

Charlotte, North Carolina, 28207, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Mercy Health Center

Oklahoma City, Oklahoma, 73120, United States

Location

OHSU

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Fort Sanders Regional Medical Center

Knoxville, Tennessee, 37916, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8896, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Sacred Heart Providence

Spokane, Washington, 99204, United States

Location

University of Wisconsin Hospital and Center

Madison, Wisconsin, 53792, United States

Location

Royal Melbourne Hospital

Parkville, 3052, Australia

Location

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Xuan Wu Hospital

Beijing, China

Location

CHU Montpelier

Montpellier, 34295, France

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg/Saar, 66421, Germany

Location

Instituto Nacional de Neurologia e Neurocirurgia

Mexico City, Mexico City, 14269, Mexico

Location

Rikshospitalet University Hospital

Oslo, 0027, Norway

Location

Hospital General

Alicante, Spain

Location

Hospital Clinico Y provincial

Barcelona, Spain

Location

Hospital Donostia

Donostia / San Sebastian, Spain

Location

Clinica Ntra Sra Del Rosario Hospital Ruber Internacional

Madrid, 28056, Spain

Location

Istanbul University Cerrahpaşa Tıp Fakültesi

Kocamustafapaşa, Istanbul, 34300, Turkey (Türkiye)

Location

The Walton Centre

Fazakerley, Liverpool, L9 7LJ, United Kingdom

Location

Newcastle General Hospital Department of Neuroradiology

Tyne and Wear, NE4 6BE, United Kingdom

Location

Related Publications (2)

• McDougall CG, Johnston SC, Gholkar A, Barnwell SL, Vazquez Suarez JC, Masso Romero J, Chaloupka JC, Bonafe A, Wakhloo AK, Tampieri D, Dowd CF, Fox AJ, Imm SJ, Carroll K, Turk AS; MAPS Investigators. Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial. AJNR Am J Neuroradiol. 2014 May;35(5):935-42. doi: 10.3174/ajnr.A3857. Epub 2014 Jan 30.

  PMID: 24481333 DERIVED

• Hetts SW, Turk A, English JD, Dowd CF, Mocco J, Prestigiacomo C, Nesbit G, Ge SG, Jin JN, Carroll K, Murayama Y, Gholkar A, Barnwell S, Lopes D, Johnston SC, McDougall C; Matrix and Platinum Science Trial Investigators. Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes. AJNR Am J Neuroradiol. 2014 Apr;35(4):698-705. doi: 10.3174/ajnr.A3755. Epub 2013 Nov 1.

  PMID: 24184523 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: S. Claiboren Johnston, MD, PhD
• Organization: University of California, UCSF Medical Center

Clay.Johnston@ucsfmedctr.org

415-502-7487

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 8, 2006
• Study Start: March 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2015
• Last Updated: February 17, 2016
• Results First Posted: March 18, 2014

Record last verified: 2016-01

Locations

ES (4); TU (1); FR (1); AU (1); DE (4); ME (1); US (26); CA (1); NO (1); CN (1); GB (2)