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Efficacy and Safety of Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Intracranial Atherosclerotic Large Vessel Occlusion (ANGEL-REBOOT 2)

2026年5月25日 更新者:Feng Gao

Efficacy and Safety of Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Intracranial Atherosclerotic Large Vessel Occlusion: A Clinical Trial Combining a Randomized Controlled Trial and a Concurrent Prospective Observational Cohort

A multicenter, randomized, open-label, blinded-endpoint trial with a concurrent prospective observational cohort to compare bailout intracranial angioplasty or stenting versus standard therapy on functional outcome, stroke recurrence, and mortality in patients with acute intracranial atherosclerotic stenosis-related large vessel occlusion after thrombectomy.

研究概览

详细说明

This is a clinical trial with a composite design, consisting of: (1) a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial (RCT) for patients with successful recanalization but residual severe stenosis (>70%) after thrombectomy, and (2) a concurrent prospective observational cohort for patients with failed recanalization. Patients with acute ischemic stroke due to intracranial atherosclerotic stenosis-related large vessel occlusion (ICAS-LVO) within 24 hours of symptom onset who undergo up to two thrombectomy passes are assessed. Those achieving successful recanalization (expanded Thrombolysis in Cerebral Infarction [eTICI] grade ≥2b) but with residual stenosis ≥70% are enrolled in the RCT and randomly assigned in a 1:1 ratio to receive either bailout angioplasty or stenting (BAOS) (intervention group) or standard therapy (control group). Randomization is performed using a centralized interactive web response system with a minimization method, stratified by baseline National Institutes of Health Stroke Scale score (6-15 vs. ≥16), time from symptom onset to puncture (≤6 hours vs. 6-24 hours), and occlusion site (anterior circulation vs. posterior circulation). For patients who fail to achieve successful recanalization (eTICI 0-2a) after at least two thrombectomy passes, they are enrolled in the concurrent prospective observational cohort without randomization, and subsequent treatment (including continued thrombectomy, BAOS, or termination of the procedure) is at the discretion of the treating physician. The primary endpoint is the modified Rankin Scale (mRS) score at 90 days (±7 days) after randomization or enrollment. Key secondary efficacy endpoints include the proportion of patients with mRS scores of 0-1, 0-2, and 0-3 at 90 days; stroke recurrence in the target vessel territory within 90 days and 1 year; NIHSS score at 24 hours; and quality of life measures at 90 days and 1 year. Safety endpoints include symptomatic intracranial hemorrhage within 24 hours (defined by the Heidelberg Bleeding Classification), any intracranial hemorrhage within 24 hours, mortality at 7 days, 90 days, and 1 year, and procedure-related complications (e.g., arterial perforation, dissection, or distal embolization). Follow-up assessments are performed at 24 hours, 7 days or discharge (whichever occurs first), 90 days, and every 3 months thereafter until 1 year after randomization or enrollment.

研究类型

介入性

注册 (估计的)

420

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100070
        • Beijing Tiantan Hospital, Capital Medical University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age≥18 years.
  2. Time interval from symptom onset to puncture ≤24 hours.
  3. National Institute of Health Stroke Scale (NIHSS) Score ≥6 before randomisation.
  4. Pre-stroke modified Rankin Scale (mRS) of 0-2.
  5. Each patient or their legal representative must provide written informed consent before enrolment.

Imaging Inclusion Criteria:

  1. For patients with anterior circulation stroke, a CT or DWI-based Alberta Stroke Program Early CT Score (ASPECTS) of ≥6 is required.
  2. For patients with posterior circulation stroke, CT or DWI-based posterior circulation ASPECTS (pc-ASPECTS) of ≥6 and Pons-Midbrain Index (PMI) of <3 are required.

Angiographic Inclusion Criteria:

  1. Acute ischemic stroke (AIS) resulting from large vessel occlusion (LVO) involving the intracranial internal carotid artery, the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, or the basilar artery, with high suspicion of intracranial atherosclerotic stenosis-related large-vessel occlusion (ICAS-LVO).
  2. Part 1 (RCT): Successful recanalization of the occluded artery (eTICI ≥ 2b) with residual stenosis ≥ 70% after 1-2 thrombectomy attempts.

    Part 2 (Prospective observational cohort): Failure to achieve successful recanalization (eTICI 0-2a) after at least two thrombectomy attempts. All other inclusion criteria are identical to those for Part 1.

  3. Occluded artery amenable to angioplasty (balloon dilation and/or stenting) by the judgement of the treating neurointerventionalist.

Exclusion Criteria:

  1. Any sign of intracranial hemorrhage (ICH, except microbleeds) on baseline brain imaging.
  2. CT or MR imaging evidence of intracranial tumor (except small meningiomas or cerebral aneurysms < 3mm in diameter).
  3. Any indication of intracranial vessel perforation during thrombectomy..
  4. Presence of tandem lesion in the extracranial segment of the internal carotid artery or vertebral artery, or intracranial arterial stenosis with distal vessel occlusion..
  5. Stenosis caused by non-atherosclerotic intracranial arteriopathies (e.g., autoimmune vasculitis, vasospasm, cerebral artery dissection).
  6. Evidence of cardioembolism (e.g., atrial fibrillation, prosthetic heart valve, infective endocarditis, mitral stenosis, atrial myxoma, intracardiac thrombus/vegetation, left ventricular aneurysm, etc.).
  7. Contraindication for antiplatelet treatment.
  8. Excessive vascular tortuosity or anatomical variants that may preclude successful delivery or positioning of interventional devices.
  9. History of contraindication to the use of contrast medium.
  10. Refractory hypertension (defined as systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment.
  11. Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.5.
  12. Blood glucose<2.8 or>22.2 mmol/L; Platelet count<100*109/L, serum creatinine>2.0 g/L (177 μ mol/L), or glomerular filtration rate<30 ml/(min*1.73 m2).
  13. Concurrent participation in another drug or device trial, or expected participation within the following 3 months.
  14. Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.).
  15. Known pregnancy or lactation, or positive pregnancy test before randomization (or before enrollment).
  16. Known dementia or psychiatric disorder that precludes completion of neurological assessments and follow-up.
  17. Any other condition deemed by the site investigator to make the patient unsuitable for participation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention group
Bailout Angioplasty or Stenting (BAOS) Group
Balloon angioplasty and/or stent placement for residual severe stenosis (≥70%) after successful thrombectomy; combined with medical management (intravenous tirofiban, followed by dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day for 90 days, then single antiplatelet therapy thereafter; and cerebrovascular risk factor management).
其他:Control group
Standard Ttherapy Group
Endovascular thrombectomy performed according to guideline recommendations, without additional endovascular intervention; combined with medical management (intravenous tirofiban as needed, dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day for 90 days, then single antiplatelet therapy thereafter; and cerebrovascular risk factor management).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The primary endpoint is the mRS score at 90 (±7) days after randomization (or after enrollment), analyzed as an ordinal variable
大体时间:90±7 days after randomization (or after enrollment)
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
90±7 days after randomization (or after enrollment)

次要结果测量

结果测量
措施说明
大体时间
The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days
大体时间:90±7 days after randomization (or after enrollment)
The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days.
90±7 days after randomization (or after enrollment)
The rate of stroke recurrence in the target vessel territory within 90 (±7) days
大体时间:90±7 days after randomization (or after enrollment)
Stroke recurrence in the target vessel territory within 90 (±7) days.
90±7 days after randomization (or after enrollment)
NIHSS score at 24 (±6/+12) hours
大体时间:24 (-6/+12) hours after randomization (or after enrollment)
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
24 (-6/+12) hours after randomization (or after enrollment)
European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 90±7 days
大体时间:90±7 days after randomization (or after enrollment)
EuroQol Five Dimensions (EQ-5D-5L) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
90±7 days after randomization (or after enrollment)
Patency of the target vessel at 24 (±6/+12) hours after the procedure, as confirmed by CTA, MRA, DSA, or TCD
大体时间:24 (-6/+12) hours after randomization (or after enrollment)
Patency of the target vessel at 24 (±6/+12) hours after the procedure, as confirmed by CTA, MRA, DSA, or TCD.
24 (-6/+12) hours after randomization (or after enrollment)
The mRS score at 1 year (±30 days), analyzed as an ordinal variable
大体时间:1 year (±30 days) after randomization (or after enrollment)
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
1 year (±30 days) after randomization (or after enrollment)
The proportion of mRS 0-1, 0-2 and 0-3 scores at 1 year (± 30 days)
大体时间:1 year (±30 days) after randomization (or after enrollment)
The proportion of mRS 0-1, 0-2 and 0-3 scores at 1 year (± 30 days).
1 year (±30 days) after randomization (or after enrollment)
The rate of stroke recurrence in the target vessel territory within 1 year (± 30 days)
大体时间:1 year (±30 days) after randomization (or after enrollment)
Stroke recurrence in the target vessel territory within 1 year (± 30 days).
1 year (±30 days) after randomization (or after enrollment)
Patency of the target vessel at 1 year (± 30 days) after the procedure, as confirmed by CTA, MRA, DSA, or TCD
大体时间:1 year (±30 days) after randomization (or after enrollment)
Patency of the target vessel at 1 year (± 30 days) after the procedure, as confirmed by CTA, MRA, DSA, or TCD.
1 year (±30 days) after randomization (or after enrollment)
European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 1 year (±30 days)
大体时间:1 year (±30 days) after randomization (or after enrollment)
EuroQol Five Dimensions (EQ-5D-5L) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
1 year (±30 days) after randomization (or after enrollment)

其他结果措施

结果测量
措施说明
大体时间
The rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 24 hours
大体时间:24 (-6/+12) hours after randomization (or after enrollment)
Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening. 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration.
24 (-6/+12) hours after randomization (or after enrollment)
The rate of all-cause mortality within 90 days
大体时间:90±7 days after randomization (or after enrollment)
All cause of mortality within 90 days.
90±7 days after randomization (or after enrollment)
The rate of any intracranial hemorrhage identified by CT or MRI imaging within 24 hours after randomization
大体时间:24 (-6/+12) hours after randomization
Any intracranial hemorrhage identified by CT or MRI imaging within 24 (-6/+12) hours after randomization.
24 (-6/+12) hours after randomization
Procedure-related complications, including arterial perforation, arterial dissection, and embolization to a new vascular territory
大体时间:At the end of the procedure or intraoperatively
Procedure-related complications, including arterial perforation, arterial dissection, and embolization to a new vascular territory.
At the end of the procedure or intraoperatively
Procedure-related complications: arterial perforation, arterial dissection, and new territorial embolism, etc
大体时间:At the end of the procedure or intraprocedurally
Procedure-related complications: arterial perforation, arterial dissection, and new territorial embolism, etc.
At the end of the procedure or intraprocedurally
The rate of all-cause mortality within 1 year (± 30 days)
大体时间:1 year (±30 days) after randomization (or after enrollment)
The rate of all-cause mortality within 1 year (±30 days).
1 year (±30 days) after randomization (or after enrollment)
The rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification or any intracranial hemorrhage within 1 year (±30 days)
大体时间:1 year (±30 days) after randomization (±30 days)
Any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification or any intracranial hemorrhage within 1 year (±30 days).
1 year (±30 days) after randomization (±30 days)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Feng Gao, MD、Beijing Tiantan Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年5月25日

首先提交符合 QC 标准的

2026年5月25日

首次发布 (实际的)

2026年6月1日

研究记录更新

最后更新发布 (实际的)

2026年6月1日

上次提交的符合 QC 标准的更新

2026年5月25日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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