Clinical trial NCT00396981: MAPS Trial: Matrix And Platinum Science
Official title: A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intracranial Aneurysms
Keywords: Intracranial saccular aneurysms
Endovascular coiling therapy
Retreatment
Raymond scale
Matrix
GDC
Guglielmi Detachable Coil
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2006-11-08
Enrollment: 626
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: Angiographic Assessments
timeFrame: Reintervention or 12 months
measure: Neurological Assessments
timeFrame: 12 months
measure: Technical Procedure Success
timeFrame: Post-procedure
measure: Target Aneurysm Recurrence
timeFrame: 2 years
measure: Target Aneurysm Recurrence
timeFrame: 3 years
measure: Target Aneurysm Recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital Barrow Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Chicago
country: United States
facility: Rush Presbyterian
state: Illinois
city: Iowa City
country: United States
facility: The Universtiy of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Worcester
state: Massachusetts
city: Southfield
country: United States
facility: Providence Detroit
state: Michigan
city: St. Paul
country: United States
facility: St. Joseph's Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: St. Louis
country: United States
facility: Barnes Jewish Mallinckrodt Institute of Radiology
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Center
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico Department of Neurosurgery
state: New Mexico
city: Stony Brook
country: United States
facility: Stony Brook Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery & Spine Associates, PA
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Health Center
state: Oklahoma
city: Portland
country: United States
facility: OHSU
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: Fort Sanders Regional Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Seattle
country: United States
facility: University of Washington Harborview Medical Center
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Providence
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Center
state: Wisconsin
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Montreal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
city: Beijing
country: China
facility: Xuan Wu Hospital
city: Montpellier
country: France
facility: CHU Montpelier
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes
city: Mexico City
country: Mexico
facility: Instituto Nacional de Neurologia e Neurocirurgia
city: Oslo
country: Norway
facility: Rikshospitalet University Hospital
city: Alicante
country: Spain
facility: Hospital General
city: Barcelona
country: Spain
facility: Hospital Clinico Y provincial
city: Madrid
country: Spain
facility: Clinica Ntra Sra Del Rosario Hospital Ruber Internacional
city: San Sebastian
country: Spain
facility: Hospital Donostia
city: Kocamustafapasa
country: Turkey
facility: Istanbul University Cerrahpaşa Tıp Fakültesi
state: Istanbul
city: Fazakerley
country: United Kingdom
facility: The Walton Centre
state: Liverpool
city: Tyne and Wear
country: United Kingdom
facility: Newcastle General Hospital Department of Neuroradiology
Study officials:
affiliation: University of California, San Francisco, CA
name: S. Claiborne Johnston, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barrow Neurological Institute, Phoenix, AZ
name: Cameron McDougall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle Upon Tyne Hospitals, NHS Trust, UK
name: Anil Gholkar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDougall CG, Johnston SC, Gholkar A, Barnwell SL, Vazquez Suarez JC, Masso 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.
citation: Hetts SW, Turk A, English JD, Dowd CF, Mocco J, Prestigiacomo C, Nesbit G, Ge SG, Jin JN, Carroll K, Murayama Y, Gholkar A, Barnwell S, Lopes D, Johnston SC, McDougall C; Matrix and Platinum Science Trial Investigators. Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes. AJNR Am J Neuroradiol. 2014 Apr;35(4):698-705. doi: 10.3174/ajnr.A3755. Epub 2013 Nov 1.