MAPS Trial: Matrix And Platinum Science

Intracranial Aneurysms Clinical Trial

— MAPS  

Official title:

A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms

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

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

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