Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion: A Multi-centered, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial (ANGEL-REBOOT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Clinical outcome 90 (±14) days after randomization on the modified Ranking Score (mRS) as an ordinal scale (shift analysis)
研究概览
简要总结
Unfavorable outcomes were associated with failed thrombectomy of acute large vessel occlusions (LVO). The failed thrombectomy rate was 12-41% reported in multiple randomized controlled trials (RCT). Possible reasons of failed thrombectomy included technical failure of access, failure of retrieving thrombus, thrombotic re-occlusion, and pre-existing intracranial atherosclerotic stenosis (ICAS). Several studies have been published on balloon dilation or permanent stenting as rescue approaches for failed thrombectomy in individual cases, but there is no evidence from RCTs regarding this topic. ANGEL-REBOOT aims to close this gap by performing a randomized study of bailout intracranial angioplasty (balloon dilation and/or stenting) for unsuccessful thrombectomy in LVO patients.
详细描述
The ANGEL-REBOOT is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE design) study. A total of approximately 348 patients within 24 hours of symptom onset of acute ischemic stroke (NIHSS≥6), who has the imaging evidence of anterior circulation stroke (CT or DWI ASPECTS≥6) or posterior circulation stroke (CT or DWI pc-ASPECTS≥6 and Pons-Midbrain Index [PMI]<3) caused by an occlusion of intracranial internal cerebral artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery (VA) or basilar artery (BA).
Randomization would take place after failed thrombectomy (defined as eTICI 0-2a or a remaining high-grade stenosis > 70% after 1-3 attempts of thrombectomy with stent retriever and/or contact aspiration). Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (bailout angioplasty or standard therapy) after offering informed content.
If the patient is randomized into the bailout angioplasty arm, the choice of balloon dilation or stenting will be left to the discretion of the interventionalist. If the patient is randomized into the standard therapy arm, the interventionalist will decide whether to stop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters.
The primary objective is to compare the efficacy and safety of bailout intracranial angioplasty with standard therapy following unsuccessful thrombectomy in acute LVO patients.
The study consists of three visits including 24 hours, 7 days or discharge, and 90 days after randomization. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment and neurological function scale will be recorded during the study. The primary endpoint is the modified Ranking Scale (mRS) at 90 days. The study is anticipated to last from December 2021 to September 2023 with 348 participants recruited form about 40 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and regulation of Chinese Good Clinical Practice. A scheduled Data and Safety Monitoring Board (DSMB) meeting will oversight the safety and data quality of the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Beijing Tiantan hospital, Capital Medical University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Clinical Inclusion criteria
- •Age ≥18 years
- •Pre-stroke mRS 0~2
- •Acute ischemic stroke (NIHSS ≥ 6)
- •Time-last-known-well to puncture ≤ 24 hours
- •Informed consent
- •Baseline Imaging Inclusion Criteria
- •1.Anterior circulation stroke: CT or DWI ASPECTS ≥ 6; Posterior circulation stroke: CT or DWI pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI)<3
- •Angiographic Inclusion Criteria
- •Acute ischemic stroke caused by LVO, including intracranial internal cerebral artery (ICA), M1 of the middle cerebral artery (MCA), V4 of vertebral artery (VA) or basilar artery (BA)
- •Failed recanalization (eTICI 0-2a) or residual severe stenosis (> 70%) after 1-3 attempts of thrombectomy with stent retriever and/or contact aspiration
- •Microcatheter can pass through the occluded segment before randomization
- •Occluded artery amenable to angioplasty by judgement of the treating neurointerventionalist
排除标准
- •Any sign of intracranial hemorrhage on brain imaging prior to thrombectomy
- •CT or MRI evidence of mass effect or intracranial tumor
- •Any sign of intracranial vessel perforation during mechanical thrombectomy prior to randomization
- •Contraindication of anti-platelet treatment
- •History of contraindication for contrast medium
- •Current use of oral anticoagulants (e.g. INR > 1.7 for Vitamin K antagonists)
- •Current pregnant or breast-feeding
- •Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
- •Life expectancy is less than 3 months
- •Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months.
- •Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
结局指标
主要结局
Clinical outcome 90 (±14) days after randomization on the modified Ranking Score (mRS) as an ordinal scale (shift analysis)
时间窗: 90±14 days after randomization
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
次要结局
- Mortality within 90 (±14) days after randomization(90±14 days after randomization)
- Technical success defined as successful recanalization (eTICI 2b-3) of the occluded vessel at the end of the procedure(The end of the procedure)
- Infarct volume on FLAIR/T2WI or CT after 18-36 hours of randomization(18-36 hours after randomization)
- Functional health status and quality of life (EQ-5D-5L) at 90 (±14) days after randomization(90±14 days after randomization)
- NIHSS score at 24 hours after randomization(24 hours after randomization)
- Proportion of target vessel recanalization at 18-36 hours after randomization(18-36 hours after randomization)
- Severe procedure-related complications (e.g. dissection of intracranial artery)(90±14 days after randomization)
- Rate of good functional outcome (mRS 0-2) at 90 (±14) days after randomization(90±14 days after randomization)
- Rate of independent ambulation (mRS 0-3) at 90 (±14) days after randomization(90±14 days after randomization)
- Symptomatic intracranial hemorrhage (SICH) defined as the Heidelberg classification within 18-36 hours of randomization(18-36 hours after randomization)
- Recurrence of ischemic stroke in downstream territory of the occluded vessel within 90 (±14) days after randomization(90±14 days after randomization)
- Parenchymal hemorrhage type 2 (PH-2) after 18-36 hours of randomization(18-36 hours after randomization)
- Infarct in new territories (INT) within 18-36 hours of randomization(18-36 hours after randomization)
研究者
Zhongrong Miao
Director of Interventional Neuroradiology, Department of Neurology
Beijing Tiantan Hospital