A Multi-centre, Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) Controlled Trial Comparing Cervical Internal Carotid Artery Stenting to no Stenting During Thrombectomy for Tandem Occlusion Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- Clinical efficacy outcome: proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2)
研究概览
简要总结
Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT).
However, the optimal treatment of acute stroke patients with TL remains uncertain, as relatively few patients with TL were included in the major randomized controlled trials of EVT and management of the c-ICA was generally not specified by protocol nor analyzed post-hoc.
Recent large multi-centre retrospective cases series suggest that acutely stented patients may have more favorable outcomes than patients treated with angioplasty alone or those with no acute ICA intervention, but high quality randomized trial data are lacking.
EASI-TOC, a phase 3, academic multi-centre, controlled trial (PROBE design) with embedded pilot phase, will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days. Patients will be randomized to Acute stenting or No acute stenting (1:1 allocation).
详细描述
EASI-TOC is a phase III multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) controlled trial (1:1 allocation).
The trial will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days (measured using the Modified Rankin Scale).
EASI-TOC will be conducted at 10-12 high-volume comprehensive stroke centres in Canada.
458 male and female adult (aged ≥ 18 years) patients will be enrolled.
Patients will be randomized (1:1) to undergo acute ICA stenting during the thrombectomy procedure (either before or after intracranial thrombectomy, at the discretion of the treating physician) or to intracranial thrombectomy alone without ICA stenting. Deferred ICA intervention is allowed, if indicated. Randomization will be centralized and web-based. Stratification will be performed for use or not of IV alteplase and for enrolling site.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
盲法说明
Open-label, blinded endpoint (PROBE)
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
- Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis:
- Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery (MCA)
- A neurological deficit judged to be disabling by the patient and/or treating physician
- Any acute imaging judged by the treating physician to demonstrate salvageable brain tissue possibly amenable to EVT
- Groin puncture within 24-hours of onset or last known normal
- Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial non-invasive vascular imaging
- Informed consent from patient or surrogate or deferral of consent, according to local ethics policies
排除标准
- Pre-existing neurological impairment (modified Rankin score ≥3)
- Any underlying disease or condition making protocol adherence and/or 3-month follow-up unlikely
- Any known contra-indication to EVT, angioplasty/stenting, or antiplatelet therapy
- Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion NOT confirmed on conventional angiography
- Ipsilateral ICA stenosis or occlusion attributable to clinically or radiologically confirmed arterial dissection
- Isolated cervical carotid occlusion without intracranial occlusion
- Pregnancy
研究组 & 干预措施
Acute Stenting
All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure.
干预措施: Carotid artery stenting (Device)
Acute Stenting
All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure.
干预措施: Antiplatelet Agents (Drug)
No Acute Stenting
All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be not revascularized with a stent during the acute thrombectomy procedure.
结局指标
主要结局
Clinical efficacy outcome: proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2)
时间窗: 90 days ± 14 days
The proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
次要结局
- Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score(24 hours ± 8 hours)
- Clinical efficacy outcome: Quality of Life(90 days +/- 14 days)
- Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score(90 days ± 14 days)
- Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) according to sex(90 days ± 14 days)
- Clinical efficacy outcome: Ordinal logistic regression for functional improvement on the Modified Rankin Scale (mRS) score (shift analysis)(90 days ± 14 days)
- Clinical efficacy outcome: Median Modified Rankin Scale (mRS) score(90 days ± 14 days)
- Clinical efficacy outcome: Rate of clinically confirmed recurrent ipsilateral stroke or retinal ischemia(90 days ± 14 days)
- Radiological efficacy outcome: Proportion of patients with complete or near-complete recanalization(End of endovascular procedure)
- Radiological efficacy outcome: Proportion of patients with ICA thrombosis (with or without stent)(90 days ± 14 days)
- Clinical efficacy outcome: Median Montreal Cognitive Assessment (MoCA) score(90 days ± 14 days)
- Clinical efficacy outcome: Rate of any recurrent stroke or retinal ischemia(1 year ± 60 days)
- Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale (mRS) score(1 year ± 60 days)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT04261478
- 其他研究编号
- MP-02-2020-8614
日期
- 首次提交
- (6年前)
- 首次发布
- (6年前)
- 主要完成日期
- (7个月后)
- 研究完成日期
- (明年)
- 最近核实
- (7个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 是
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Upon completion of the EASI-TOC Trial, a public use database will be prepared by stripping any and all personal identifiers. The public use database, consisting of several data files, should contain: (1) baseline and demographic characteristics; (2) outcomes assessments; (3) imaging data; (4) serious adverse events.
These data files will be made available to researchers with validated requests only after all major manuscripts (including secondary analysis papers) of the Trial are accepted for publication in peer-reviewed journals.