Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00396981
Study type Interventional
Source Stryker Neurovascular
Contact
Status Completed
Phase Phase 4
Start date March 2007
Completion date March 2015

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02879175 - Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms
Completed NCT01139892 - The Canadian UnRuptured Endovascular Versus Surgery Trial (CURES)
Recruiting NCT06411418 - Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm N/A
Completed NCT02312856 - Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction N/A
Recruiting NCT01054391 - Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae N/A
Completed NCT02657772 - Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms
Completed NCT01465841 - Study of the Penumbra Coil 400 System to Treat Aneurysm N/A
Enrolling by invitation NCT05453240 - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
Completed NCT03550638 - Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms N/A
Terminated NCT02122133 - CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
Completed NCT01541254 - Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device Phase 2/Phase 3
Terminated NCT01320306 - Intracranial Aneurysms and Cognitive Function
Recruiting NCT01084681 - Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques N/A
Completed NCT02921711 - TRAIL: Treatment of Intracranial Aneurysms With LVIS® System
Recruiting NCT01031147 - Contrast-free Magnetic Resonance Angiography (MRA) at 3.0 T for Intracranial Aneurysm Detection N/A
Recruiting NCT05636124 - Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms N/A
Completed NCT02921698 - Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Completed NCT01801007 - Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms N/A
Terminated NCT01974700 - Seizure Prophylaxis in Aneurysm Repair Phase 4
Completed NCT01793792 - Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support) N/A