A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 626
- 试验地点
- 82
- 主要终点
- Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 80 years of age (inclusive).
- •Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils.
- •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).
- •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.
- •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.
- •Patient (or patient's legally authorized representative for centers in the United States) has provided written informed consent.
- •Patient is willing and able to comply with protocol follow-up requirements.
排除标准
- •Patient is < 18 or > 80 years old.
- •Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting).
- •Target aneurysm is > 20 mm maximum luminal dimension, < 4 mm maximum luminal dimension.
- •Target aneurysm has been previously treated by surgery or endovascular therapy.
- •Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.
- •Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm.
- •Patient presents with Modified Rankin Score 4 or 5 at baseline.
- •Patient is concurrently enrolled in another investigational drug or device study unless permission is granted by the sponsor.
- •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.
- •Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure.
- •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.
- •Planned use of adjunctive therapy stents except Neuroform is not allowed.
- •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.
- •Patients with multiple aneurysms.
- •Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion of the investigator.
- •Female patient has a positive pregnancy assessment at baseline.
结局指标
主要结局
Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.
时间窗: 12 months
次要结局
- Angiographic Assessments(Reintervention or 12 months)
- Neurological Assessments(12 months)
- Technical Procedure Success(Post-procedure)
- Target Aneurysm Recurrence(5 years)