A Single-center, Prospective, Cohort Study of the Safety and Efficacy of Single Antiplatelet Therapy After Pipeline Flex with Shield Stent Implantation for Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Hemorrhagic, ischemic events, or neurological deficits occurring within 6 months postoperatively.
研究概览
简要总结
The objective of this study was to evaluate the safety and efficacy of single antiplatelet therapy after Pipeline flex with Shield stent implantation for intracranial aneurysms.
详细描述
Title：A single-center, prospective, cohort study of the safety and efficacy of Single Antiplatelet therapy after Pipeline flex with Shield stent implantation for intracranial aneurysms.
Purpose：To assess the safety and efficacy of single antiplatelet therapy after Pipeline flex with Shield stent implantation for intracranial aneurysms.
Follow up:The follow-up period was 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with unruptured intracranial aneurysms who received the intracranial Pipeline Flex with Shield stent.
- •Vascular conditions:
- •There was no obvious calcification and stenosis of the parent artery. 2) The curvature of the bearing artery is minimal. 3) The parent artery diameter ≥2.5mm
- •3.According to the committee's assessment, only one Pipeline flex with shield is needed for aneurysm treatment.
- •4.Before the stent implantation procedure, standard dual antiplatelet therapy should be administered for at least 3 days.
- •5.Patients with an Modified Rankin Scale(mRS) score of less than 2 on the day of registration.
- •6.The operation was successful, and immediate postoperative angiography indicated good wall apposition.
排除标准
- •Patients with recurrent aneurysms after interventional treatment or surgical clipping.
- •The patient after stent placement surgery.
- •Aneurysms can have irregular shapes, such as fusiform, blister-type, or dissecting aneurysms.
- •The patient had no history of stroke or aneurysm rupture in the last 3 months.
- •Abnormal platelet function, or platelet count < 100,000 cells/mm³.
- •Known history of allergy to clopidogrel or heparin.
结局指标
主要结局
Hemorrhagic, ischemic events, or neurological deficits occurring within 6 months postoperatively.
时间窗: assessed at 6 months after procedure
Ischemic events include intraoperative and postoperative ischemic stroke, transient ischemic attack, stent thrombosis, emergency revascularization, and cerebrovascular death. Hemorrhagic events include: symptomatic or asymptomatic intracranial hemorrhagic events (subarachnoid hemorrhage and intracerebral hemorrhage) within 6 months after surgery; or non-intracranial hemorrhagic events (such as skin petechiae, epistaxis, gingival bleeding, gastrointestinal bleeding, genitourinary bleeding, etc.).
Rate of complete aneurysm occlusion in 6 months
时间窗: assessed at 6 months after procedure
The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond-Roy occlusion classification Scale at the 6 months follow-up angiographic assessments will be evaluated.
次要结局
未报告次要终点