MAPS Trial: Matrix And Platinum Science

NCT ID: NCT00396981

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 626 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2015-03-31

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.

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 rupture/re-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, rupture/re-rupture and/or 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.

Conditions

Intracranial Aneurysms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Matrix 2® Coils

Matrix 2® Coils for endovascular aneurysm occlusion

Group Type: ACTIVE_COMPARATOR

Matrix 2® coils for endovascular aneurysm occlusion

Intervention Type: DEVICE

endovascular aneurysm occlusion coil

GDC® Coils

GDC® Coils for endovascular aneurysm occlusion

Group Type: ACTIVE_COMPARATOR

GDC® coils for endovascular aneurysm occlusion

Intervention Type: DEVICE

endovascular aneurysm occlusion coil

Interventions

Matrix 2® coils for endovascular aneurysm occlusion

endovascular aneurysm occlusion coil

Intervention Type: DEVICE

GDC® coils for endovascular aneurysm occlusion

endovascular aneurysm occlusion coil

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient is between 18 and 80 years of age (inclusive).

2. Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils.

3. 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).

4. 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.

5. 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.

6. Patient (or patient's legally authorized representative for centers in the United States) has provided written informed consent.

7. Patient is willing and able to comply with protocol follow-up requirements.

Exclusion Criteria

1. Patient is < 18 or > 80 years old.

2. Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting).

3. Target aneurysm is > 20 mm maximum luminal dimension, < 4 mm maximum luminal dimension.

4. Target aneurysm has been previously treated by surgery or endovascular therapy.

5. Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.

6. Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm.

7. Patient presents with Modified Rankin Score 4 or 5 at baseline.

8. Patient is concurrently enrolled in another investigational drug or device study unless permission is granted by the sponsor.

9. 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.

10. Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure.

11. 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.

12. Planned use of adjunctive therapy stents except Neuroform is not allowed.

13. 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.

14. Patients with multiple aneurysms.

15. Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion of the investigator.

16. Female patient has a positive pregnancy assessment at baseline.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Neurovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

S. Claiborne Johnston, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco, CA

Cameron McDougall, MD

Role: PRINCIPAL_INVESTIGATOR

Barrow Neurological Institute, Phoenix, AZ

Anil Gholkar, MD

Role: PRINCIPAL_INVESTIGATOR

Newcastle Upon Tyne Hospitals, NHS Trust, UK

Locations

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

University of Wisconsin Hospital and Center

Madison, Wisconsin, United States

Royal Melbourne Hospital

Parkville, , Australia

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

Xuan Wu Hospital

Beijing, , China

CHU Montpelier

Montpellier, , France

Klinikum Augsburg

Augsburg, , Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

Asklepios Klinik Altona

Hamburg, , Germany

Universitaetsklinikum des Saarlandes

Homburg/Saar, , Germany

Instituto Nacional de Neurologia e Neurocirurgia

Mexico City, Mexico City, Mexico

Rikshospitalet University Hospital

Oslo, , Norway

Hospital General

Alicante, , Spain

Hospital Clinico Y provincial

Barcelona, , Spain

Hospital Donostia

Donostia / San Sebastian, , Spain

Clinica Ntra Sra Del Rosario Hospital Ruber Internacional

Madrid, , Spain

Istanbul University Cerrahpaşa Tıp Fakültesi

Kocamustafapaşa, Istanbul, Turkey (Türkiye)

The Walton Centre

Fazakerley, Liverpool, United Kingdom

Newcastle General Hospital Department of Neuroradiology

Tyne and Wear, , United Kingdom

Countries

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

References

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.

Reference Type: DERIVED

PMID: 24481333 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24184523 (View on PubMed)

Other Identifiers

BSC0015

Identifier Type: OTHER

Identifier Source: secondary_id

T4902

Identifier Type: -

Identifier Source: org_study_id