MAPS Trial: Matrix And Platinum Science (MAPS)

A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: Matrix 2® coils for endovascular aneurysm occlusion; Device: GDC® coils for endovascular aneurysm occlusion

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.

• Study Type: Interventional
• Enrollment (Actual): 626
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Parkville, Australia, 3052
    • Royal Melbourne Hospital
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute and Hospital
• China
  • Beijing, China
    • Xuan Wu Hospital
• France
  • Montpellier, France, 34295
    • CHU Montpelier
• Germany
  • Augsburg, Germany, 86156
    • Klinikum Augsburg
  • Freiburg, Germany, 79106
    • Universitaetsklinikum Freiburg
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Homburg/Saar, Germany, 66421
    • Universitaetsklinikum des Saarlandes
• Mexico
  • Mexico City, Mexico, 14269
    • Instituto Nacional de Neurologia e Neurocirurgia
• Norway
  • Oslo, Norway, 0027
    • Rikshospitalet University Hospital
• Spain
  • Alicante, Spain
    • Hospital General
  • Barcelona, Spain
    • Hospital Clinico Y Provincial
  • Madrid, Spain, 28056
    • Clinica Ntra Sra Del Rosario Hospital Ruber Internacional
  • San Sebastian, Spain
    • Hospital Donostia
• Turkey
  • Istanbul
    • Kocamustafapasa, Istanbul, Turkey, 34300
      • Istanbul University Cerrahpaşa Tıp Fakültesi
• United Kingdom
  • Tyne and Wear, United Kingdom, NE4 6BE
    • Newcastle General Hospital Department of Neuroradiology
  • Liverpool
    • Fazakerley, Liverpool, United Kingdom, L9 7LJ
      • The Walton Centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital Barrow Neurological Institute
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Rush Presbyterian
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The Universtiy of Iowa
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Worcester
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Providence Detroit
  • Minnesota
    • St. Paul, Minnesota, United States, 55104
      • St. Joseph's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • St. Louis, Missouri, United States, 63110
      • Barnes Jewish Mallinckrodt Institute of Radiology
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Sunrise Hospital and Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Department of Neurosurgery
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Carolina Neurosurgery & Spine Associates, PA
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Mercy Health Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Fort Sanders Regional Medical Center
  • Texas
    • Dallas, Texas, United States, 75390-8896
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Methodist Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Harborview Medical Center
    • Spokane, Washington, United States, 99204
      • Sacred Heart Providence
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Matrix 2® Coils; Matrix 2® Coils for endovascular aneurysm occlusion	Device: Matrix 2® coils for endovascular aneurysm occlusion; endovascular aneurysm occlusion coil
Active Comparator: GDC® Coils; GDC® Coils for endovascular aneurysm occlusion	Device: GDC® coils for endovascular aneurysm occlusion; endovascular aneurysm occlusion coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic Assessments	Number of participants with angiographic assessment of "complete obliteration".	Reintervention or 12 months
Neurological Assessments	The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects "same or better".	12 months
Technical Procedure Success		Post-procedure
Target Aneurysm Recurrence		2 years
Target Aneurysm Recurrence		3 years
Target Aneurysm Recurrence		5 years

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: November 6, 2006
• First Submitted That Met QC Criteria: November 6, 2006
• First Posted (Estimate): November 8, 2006

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Retreatment; Matrix; Intracranial saccular aneurysms; Endovascular coiling therapy; Raymond scale; GDC; Guglielmi Detachable Coil
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: T4902; BSC0015 (Other Identifier: Stryker Neurovascular)