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MAPS Trial: Matrix And Platinum Science (MAPS)

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ClinicalTrials.gov Identifier: NCT00396981
Recruitment Status : Completed
First Posted : November 8, 2006
Results First Posted : March 18, 2014
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Tracking Information
First Submitted Date  ICMJE November 6, 2006
First Posted Date  ICMJE November 8, 2006
Results First Submitted Date  ICMJE February 7, 2013
Results First Posted Date  ICMJE March 18, 2014
Last Update Posted Date February 17, 2016
Study Start Date  ICMJE March 2007
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2006)
Target Aneurysm Recurrence (TAR) defined as clinically relevant recurrence resulting in target aneurysm reintervention, rupture/re-rupture and/or patient death (neurological or procedurally related) at 12 months ±3 months post procedure.
Change History Complete list of historical versions of study NCT00396981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2015)
  • Angiographic Assessments [ Time Frame: Reintervention or 12 months ]
    Number of participants with angiographic assessment of "complete obliteration".
  • Neurological Assessments [ Time Frame: 12 months ]
    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 ]
  • Target Aneurysm Recurrence [ Time Frame: 2 years ]
  • Target Aneurysm Recurrence [ Time Frame: 3 years ]
  • Target Aneurysm Recurrence [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2006)
  • Angiographic assessments performed at reintervention or 12 months ±3 months post-procedure
  • TAR rates stratified by aneurysm location, aneurysm size, neck size, packing density, rupture status, flow orientation and use of adjunctive devices.
  • Per protocol analysis
  • Time to first occurrence of TAR
  • Modified Raymond Scale
  • Same Better Worse Scale
  • Neurological Assessments
  • Device or procedure-related adverse events occurring at 12 months ±3 months post procedure
  • Technical procedural success
  • Quantitative measurements of aneurysm occlusion and packing density
  • TAR at 2, 3, 4, and 5 years post procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MAPS Trial: Matrix And Platinum Science
Official Title  ICMJE A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intracranial Aneurysms
Intervention  ICMJE
  • Device: Matrix 2® coils for endovascular aneurysm occlusion
    endovascular aneurysm occlusion coil
  • Device: GDC® coils for endovascular aneurysm occlusion
    endovascular aneurysm occlusion coil
Study Arms  ICMJE
  • Active Comparator: Matrix 2® Coils
    Matrix 2® Coils for endovascular aneurysm occlusion
    Intervention: Device: Matrix 2® coils for endovascular aneurysm occlusion
  • Active Comparator: GDC® Coils
    GDC® Coils for endovascular aneurysm occlusion
    Intervention: Device: GDC® coils for endovascular aneurysm occlusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2011)
626
Original Enrollment  ICMJE
 (submitted: November 6, 2006)
630
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   China,   France,   Germany,   Mexico,   Norway,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00396981
Other Study ID Numbers  ICMJE T4902
BSC0015 ( Other Identifier: Stryker Neurovascular )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stryker Neurovascular
Study Sponsor  ICMJE Stryker Neurovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Stryker Neurovascular
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP