MAPS Trial: Matrix And Platinum Science
Condition: Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Intervention: Matrix 2® coils for endovascular aneurysm occlusion; GDC® coils for endovascular aneurysm occlusion
Intervention description: endovascular aneurysm occlusion coil; endovascular aneurysm occlusion coil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 626.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Intracranial saccular aneurysms; Endovascular coiling therapy; Retreatment; Raymond scale; Matrix; GDC; Guglielmi Detachable Coil

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.
    

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.