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

November 6, 2006
March 17, 2014
March 2007
January 2011   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00396981 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
MAPS Trial: Matrix And Platinum Science
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Intracranial Aneurysms
  • Device: Matrix 2® coils for endovascular aneurysm occlusion
    endovascular aneurysm occlusion coil
  • Device: GDC® coils for endovascular aneurysm occlusion
    endovascular aneurysm occlusion coil
  • Active Comparator: 1
    Matrix 2® Coils for endovascular aneurysm occlusion
    Intervention: Device: Matrix 2® coils for endovascular aneurysm occlusion
  • Active Comparator: 2
    GDC® Coils for endovascular aneurysm occlusion
    Intervention: Device: GDC® coils for endovascular aneurysm occlusion
McDougall CG, Johnston SC, Gholkar A, Barnwell SL, Vazquez Suarez JC, Massó 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
626
March 2015
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   France,   Spain,   Mexico,   Turkey,   Canada,   United Kingdom,   Norway,   Australia,   China
 
NCT00396981
T4902, BSC0015
Yes
Stryker Neurovascular
Stryker Neurovascular
Not Provided
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
Stryker Neurovascular
February 2013

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