Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Favorable outcome
研究概览
简要总结
Evidence regarding the role of early (<24 hours) antithrombotics post-revascularization with either intravenous thrombolysis (IVT), endovascular thrombectomy (EVT), or a combination of both remains scarce. In 2018 the American Heart Association/American Stroke Association changed their recommendation, stating that the risk of antithrombotic therapy within the first 24 hours after treatment with IVT (with or without EVT) is uncertain. This was changed after data emerged that early antithrombotics may be safe and may improve outcomes in select patients undergoing EVT.
Recently the investigators showed for the first time that significant residual basilar thrombus can exist after EVT despite complete angiographic revascularization using endovascular optical coherence tomography imaging. This residual thrombus could cause ongoing function-limiting strokes with occlusion of vital basilar perforators after EVT. Therefore, the investigators propose a prospective,non-randomized safety study to evaluate optical coherence tomography guided antithrombotic management for patients with confirmed residual thrombus after EVT for basilar occlusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •All patients deemed candidates for endovascular thrombectomy(EVT) for basilar artery occlusion. As no robust guidelines exist for the role of EVT in patients with acute basilar artery occlusion, the decision for EVT is made by a team of stroke neurologist and neuro-interventionalist at our regional stroke center.
排除标准
- •High-density lesion consistent with hemorrhage of any degree.
- •Significant established infarct size.
- •Contraindication to receiving post-revascularization antithrombotics for any reason (history of major hemorrhage in the past six months, hereditary or acquired bleeding diathesis, major surgery within last three months, platelets <100 X 109 /L, coagulation factor deficiency, already on anticoagulant that would not allow administration of UFH)
- •Informed consent is not or cannot be obtained.
- •Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
- •Other serious, advanced, or terminal illness.
- •Patients who require hemodialysis or peritoneal dialysis.
- •Uncontrolled hypertension defined as systolic blood pressure>185 mm Hg or diastolic blood pressure>110mm Hg that cannot be controlled except with continuous parenteral antihypertensive medication
研究组 & 干预措施
Optical coherence tomography confirmed residual thrombus
Early antithrombotics
干预措施: Unfractionated heparin (Drug)
Optical coherence tomography confirmed residual thrombus
Early antithrombotics
干预措施: Acetylsalicylic Acid (ASA) (Drug)
结局指标
主要结局
Favorable outcome
时间窗: 90 days
Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
次要结局
- Symptomatic Intracranial Hemorrhage(24 hours CT imaging ± 8 hours.)
- Excellent Outcome(90 days)
- Incidence of residual thrombus(Immediately after endovascular thrombectomy)
研究者
Dr. Victor Yang
Neurosurgeon
Sunnybrook Health Sciences Centre