Prospective, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Endovascular Treatment in Patients With Cerebral Aneurysms Using P64 and P48 Flow-Diverter Stents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Effectiveness objective
研究概览
简要总结
The use of flow-diverting stents for the endovascular treatment of cerebral aneurysms has proven to be effective and efficient in several clinical studies, leading to its widespread adoption. Devices with a higher number of filaments have a greater flow-diverting effect and less variation when there are changes in the caliber of the underlying vessel or in curved vessels. However, ischemic complications secondary to their implantation have been reported, prompting the development of various strategies to reduce their thrombogenicity. Phenox is the only company to date that has developed an anti-thrombogenic coating, known as HPC (Hydrophilic Polymer Coating), which, when applied to the p64 MW HPC and p48 MW HPC devices, has shown to reduce the likelihood of thromboembolic complications associated with their implantation.
详细描述
The goal of this study is to evaluate the effectiveness and safety of endovascular treatment for cerebral aneurysms using the flow-diverting stents p64MW (flow modulation device) HPC and p48MW HPC in the routine clinical practice of several Spanish hospitals. It is therefore an observational study, carried out with devices already commercialized. The success rate of the intervention, the rate of hemorrhagic and thromboembolic complications, as well as variables related to the clinical and radiological follow-up of patients over a 12-month period, will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms.
- •Signed informed consent by the patient or their representative.
排除标准
- •Patients under 18 years of age.
- •Absence of signed informed consent by the patient or their representative.
- •Known, medically untreatable allergy to iodinated contrast.
- •Pregnant women or those breastfeeding.
结局指标
主要结局
Effectiveness objective
时间窗: 1 year
Evaluation of the effectiveness of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
Safety Objective
时间窗: 1 year
Evaluation of the safety of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
次要结局
- Hemorrhagic complications(1 year)
- Intimal hyperplasia(1 year)
- Intervention success(During the procedure)
- Clinical evolution of the patient using the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS).(1 year)
- Thromboembolic complications with a single antiplatelet drug(1 year)
- Thromboembolic complications(1 year)
- Mortality(1 year)
- Visible ischemic complications(6 months)
- Aneurysm occlusion(1 year)
- Intimal hyperplasia with a single antiplatelet drug(1 year)
研究者
Pedro Vega Valdes
PEDRO VEGA VALDES
Hospital Universitario Central de Asturias