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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00396981
Other study ID # T4902
Secondary ID BSC0015
Status Completed
Phase Phase 4
First received November 6, 2006
Last updated January 19, 2016
Start date March 2007
Est. completion date March 2015

Study information

Verified date January 2016
Source Stryker Neurovascular
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 626
Est. completion date March 2015
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Matrix 2® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
GDC® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil

Locations

Country Name City State
Australia Royal Melbourne Hospital Parkville
Canada Montreal Neurological Institute and Hospital Montreal Quebec
China Xuan Wu Hospital Beijing
France CHU Montpelier Montpellier
Germany Klinikum Augsburg Augsburg
Germany Universitaetsklinikum Freiburg Freiburg
Germany Asklepios Klinik Altona Hamburg
Germany Universitaetsklinikum des Saarlandes Homburg/Saar
Mexico Instituto Nacional de Neurologia e Neurocirurgia Mexico City
Norway Rikshospitalet University Hospital Oslo
Spain Hospital General Alicante
Spain Hospital Clinico Y provincial Barcelona
Spain Clinica Ntra Sra Del Rosario Hospital Ruber Internacional Madrid
Spain Hospital Donostia San Sebastian
Turkey Istanbul University Cerrahpasa Tip Fakültesi Kocamustafapasa Istanbul
United Kingdom The Walton Centre Fazakerley Liverpool
United Kingdom Newcastle General Hospital Department of Neuroradiology Tyne and Wear
United States University of New Mexico Department of Neurosurgery Albuquerque New Mexico
United States University of Maryland Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Carolina Neurosurgery & Spine Associates, PA Charlotte North Carolina
United States Rush Presbyterian Chicago Illinois
United States Cleveland Clinic Foundation Cleveland Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States Methodist Hospital Houston Texas
United States The Universtiy of Iowa Iowa City Iowa
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Fort Sanders Regional Medical Center Knoxville Tennessee
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University of Wisconsin Hospital and Center Madison Wisconsin
United States Yale-New Haven Hospital New Haven Connecticut
United States Mercy Health Center Oklahoma City Oklahoma
United States St. Joseph's Hospital Barrow Neurological Institute Phoenix Arizona
United States OHSU Portland Oregon
United States University of Washington Harborview Medical Center Seattle Washington
United States Providence Detroit Southfield Michigan
United States Sacred Heart Providence Spokane Washington
United States Barnes Jewish Mallinckrodt Institute of Radiology St. Louis Missouri
United States St. Joseph's Hospital St. Paul Minnesota
United States Stony Brook Medical Center Stony Brook New York
United States Tucson Medical Center Tucson Arizona
United States University of Massachusetts Worcester Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  France,  Germany,  Mexico,  Norway,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Angiographic Assessments Number of participants with angiographic assessment of "complete obliteration". Reintervention or 12 months Yes
Secondary 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 Yes
Secondary Technical Procedure Success Post-procedure Yes
Secondary Target Aneurysm Recurrence 2 years Yes
Secondary Target Aneurysm Recurrence 3 years Yes
Secondary Target Aneurysm Recurrence 5 years Yes
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