View clinical trials related to Intracranial Aneurysms.
Filter by:The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.
This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.
The investigators designed a double-blind, randomized placebo-controlled study to determine the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils.
This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.
Purpose: Phase 1: (Pilot Phase) To compare the treatment efficacy of surgical clipping and endovascular coiling for unruptured intracranial aneurysms. To obtain better estimates of morbidity and mortality related to a surgical or endovascular treatment strategy at one year within the context of an RCT. To show that an RCT comparing the morbidity and mortality of a surgical management strategy to an endovascular management strategy is feasible. Phase 2: To compare the results of surgical and endovascular management strategies, in terms of: 1. Overall mortality and morbidity at 1 and 5 years. 2. The clinical efficacy and safety of a surgical or endovascular management strategy at 1 and 5 years Hypotheses: Phase 1 Hypotheses: 1. Surgical clipping of intradural, saccular, unruptured intracranial aneurysms is superior to endovascular management in terms of a lesser number of patients experiencing treatment failure. 2. An RCT comparing the clinical outcomes of a surgical versus endovascular management strategy is feasible. Phase 1 Primary End-points: • Treatment failure, hereby defined as having occurred when either: the intended initial modality (surgical or endovascular) fails to occlude the aneurysm, a "major" (saccular) angiographic aneurysm recurrence is found, or an intracranial hemorrhagic event occurs during the 1-year follow-up period. Phase 1 Secondary End-points: 1. Overall morbidity and mortality at one year. 2. Occurrence of morbidity (mRS >2) or mortality following treatment. 3. Occurrence of failure of aneurysm occlusion using the initial intended treatment modality. 4. Occurrence of a "major" (saccular) angiographic aneurysm recurrence. 5. Occurrence of an intracranial hemorrhage following treatment. 6. Peri-treatment hospitalization lasting more than 5 days 7. Discharge following treatment to a location other than home Treatment: Trial feasibility, or the capacity for patient recruitment, would require enrollment of at least 8 patients per actively recruiting center per year. Phase 2 Hypotheses: It may be too early to explicitly define the primary hypothesis of Phase 2, however, the intent of Phase 2 can be expressed as: 1. One management strategy is superior to the other in terms of clinical outcome at five years. 2. One management strategy is superior to the other in terms of clinical efficacy at five years.
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.