MAPS Trial: Matrix And Platinum Science

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00396981
First received: November 6, 2006
Last updated: March 17, 2014
Last verified: February 2013
  Purpose

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.

Condition Intervention Phase
Intracranial Aneurysms
Device: Matrix 2® coils for endovascular aneurysm occlusion
Device: GDC® coils for endovascular aneurysm occlusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms

Resource links provided by NLM:


Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Angiographic Assessments [ Time Frame: Reintervention or 12 months ] [ Designated as safety issue: Yes ]
    Number of participants with angiographic assessment of "complete obliteration".

  • Neurological Assessments [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects "same or better".

  • Technical Procedure Success [ Time Frame: Post-procedure ] [ Designated as safety issue: Yes ]

Enrollment: 626
Study Start Date: March 2007
Estimated Study Completion Date: March 2015
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Matrix 2® Coils for endovascular aneurysm occlusion
Device: Matrix 2® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
Active Comparator: 2
GDC® Coils for endovascular aneurysm occlusion
Device: GDC® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396981

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

No publications provided by Stryker Neurovascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT00396981     History of Changes
Other Study ID Numbers: T4902, BSC0015
Study First Received: November 6, 2006
Results First Received: February 7, 2013
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stryker Neurovascular:
Intracranial saccular aneurysms
Endovascular coiling therapy
Retreatment
Raymond scale
Matrix
GDC
Guglielmi Detachable Coil

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014