Full Text View
Tabular View
No Study Results Posted
Related Studies
MAPS Trial: Matrix And Platinum Science
This study is currently recruiting participants.
Verified by Boston Scientific Corporation, July 2009
First Received: November 6, 2006   Last Updated: July 9, 2009   History of Changes
Sponsored by: Boston Scientific Corporation
Information provided by: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00396981
  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 neurologic death
  • 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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 Boston Scientific Corporation:

Primary Outcome Measures:
  • Target Aneurysm Recurrence (TAR) defined as clinically relevant recurrence resulting in target aneurysm reintervention, rupture/re-rupture and/or neurologic patient death. [ 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 ]
  • Per protocol analysis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Neurological Assessments [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Technical procedure success [ Time Frame: Post-procedure ] [ Designated as safety issue: Yes ]
  • TAR during long term follow-up [ Time Frame: 2, 3, 4, 5 years post-procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 630
Study Start Date: March 2007
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Matrix 2® Coils
Device: Matrix 2® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
2: Active Comparator
GDC® Coils
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 neurologic death 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396981

Contacts
Contact: Martha Conley 510-440-7830 Martha.Conley@bsci.com
Contact: David Hess 510-440-7749 David.Hess@bsci.com

  Show 45 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
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

Responsible Party: Boston Scientific ( David Hess )
Study ID Numbers: T4902, BSC0015
Study First Received: November 6, 2006
Last Updated: July 9, 2009
ClinicalTrials.gov Identifier: NCT00396981     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Intracranial saccular aneurysms
Endovascular coiling therapy
Retreatment
Raymond scale
Matrix
GDC
Guglielmi Detachable Coil

Study placed in the following topic categories:
Intracranial Aneurysm
Aneurysm
Vascular Diseases
Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases

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

ClinicalTrials.gov processed this record on September 01, 2009