MAPS Trial: Matrix And Platinum Science
Condition: Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Matrix 2® coils for endovascular aneurysm occlusion; GDC® coils for endovascular aneurysm occlusion
Intervention type(s): Device; Device
Intervention description(s): endovascular aneurysm occlusion coil; endovascular aneurysm occlusion coil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intracranial saccular aneurysms; Endovascular coiling therapy; Retreatment; Raymond scale; Matrix; GDC; Guglielmi Detachable Coil