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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
420
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Feng Gao, MD
- 電話番号:13581936066
- メール:gaofengletter@sina.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100070
- Beijing Tiantan Hospital, Capital Medical University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age≥18 years.
- Time interval from symptom onset to puncture ≤24 hours.
- National Institute of Health Stroke Scale (NIHSS) Score ≥6 before randomisation.
- Pre-stroke modified Rankin Scale (mRS) of 0-2.
- Each patient or their legal representative must provide written informed consent before enrolment.
Imaging Inclusion Criteria:
- For patients with anterior circulation stroke, a CT or DWI-based Alberta Stroke Program Early CT Score (ASPECTS) of ≥6 is required.
- 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:
- 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).
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.
- Occluded artery amenable to angioplasty (balloon dilation and/or stenting) by the judgement of the treating neurointerventionalist.
Exclusion Criteria:
- Any sign of intracranial hemorrhage (ICH, except microbleeds) on baseline brain imaging.
- CT or MR imaging evidence of intracranial tumor (except small meningiomas or cerebral aneurysms < 3mm in diameter).
- Any indication of intracranial vessel perforation during thrombectomy..
- Presence of tandem lesion in the extracranial segment of the internal carotid artery or vertebral artery, or intracranial arterial stenosis with distal vessel occlusion..
- Stenosis caused by non-atherosclerotic intracranial arteriopathies (e.g., autoimmune vasculitis, vasospasm, cerebral artery dissection).
- Evidence of cardioembolism (e.g., atrial fibrillation, prosthetic heart valve, infective endocarditis, mitral stenosis, atrial myxoma, intracardiac thrombus/vegetation, left ventricular aneurysm, etc.).
- Contraindication for antiplatelet treatment.
- Excessive vascular tortuosity or anatomical variants that may preclude successful delivery or positioning of interventional devices.
- History of contraindication to the use of contrast medium.
- Refractory hypertension (defined as systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment.
- Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.5.
- 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).
- Concurrent participation in another drug or device trial, or expected participation within the following 3 months.
- Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.).
- Known pregnancy or lactation, or positive pregnancy test before randomization (or before enrollment).
- Known dementia or psychiatric disorder that precludes completion of neurological assessments and follow-up.
- Any other condition deemed by the site investigator to make the patient unsuitable for participation.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Intervention group
Bailout Angioplasty or Stenting (BAOS) Group
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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).
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他の:Control group
Standard Ttherapy Group
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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).
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The primary endpoint is the mRS score at 90 (±7) days after randomization (or after enrollment), analyzed as an ordinal variable
時間枠:90±7 days after randomization (or after enrollment)
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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.
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90±7 days after randomization (or after enrollment)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days
時間枠:90±7 days after randomization (or after enrollment)
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The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days.
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90±7 days after randomization (or after enrollment)
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The rate of stroke recurrence in the target vessel territory within 90 (±7) days
時間枠:90±7 days after randomization (or after enrollment)
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Stroke recurrence in the target vessel territory within 90 (±7) days.
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90±7 days after randomization (or after enrollment)
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NIHSS score at 24 (±6/+12) hours
時間枠:24 (-6/+12) hours after randomization (or after enrollment)
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The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
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24 (-6/+12) hours after randomization (or after enrollment)
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European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 90±7 days
時間枠: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.
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90±7 days after randomization (or after enrollment)
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Patency of the target vessel at 24 (±6/+12) hours after the procedure, as confirmed by CTA, MRA, DSA, or TCD
時間枠:24 (-6/+12) hours after randomization (or after enrollment)
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Patency of the target vessel at 24 (±6/+12) hours after the procedure, as confirmed by CTA, MRA, DSA, or TCD.
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24 (-6/+12) hours after randomization (or after enrollment)
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The mRS score at 1 year (±30 days), analyzed as an ordinal variable
時間枠:1 year (±30 days) after randomization (or after enrollment)
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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.
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1 year (±30 days) after randomization (or after enrollment)
|
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The proportion of mRS 0-1, 0-2 and 0-3 scores at 1 year (± 30 days)
時間枠: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).
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1 year (±30 days) after randomization (or after enrollment)
|
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The rate of stroke recurrence in the target vessel territory within 1 year (± 30 days)
時間枠:1 year (±30 days) after randomization (or after enrollment)
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Stroke recurrence in the target vessel territory within 1 year (± 30 days).
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1 year (±30 days) after randomization (or after enrollment)
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Patency of the target vessel at 1 year (± 30 days) after the procedure, as confirmed by CTA, MRA, DSA, or TCD
時間枠: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.
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1 year (±30 days) after randomization (or after enrollment)
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|
European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 1 year (±30 days)
時間枠: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.
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1 year (±30 days) after randomization (or after enrollment)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 24 hours
時間枠:24 (-6/+12) hours after randomization (or after enrollment)
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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.
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24 (-6/+12) hours after randomization (or after enrollment)
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The rate of all-cause mortality within 90 days
時間枠:90±7 days after randomization (or after enrollment)
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All cause of mortality within 90 days.
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90±7 days after randomization (or after enrollment)
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The rate of any intracranial hemorrhage identified by CT or MRI imaging within 24 hours after randomization
時間枠:24 (-6/+12) hours after randomization
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Any intracranial hemorrhage identified by CT or MRI imaging within 24 (-6/+12) hours after randomization.
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24 (-6/+12) hours after randomization
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Procedure-related complications, including arterial perforation, arterial dissection, and embolization to a new vascular territory
時間枠:At the end of the procedure or intraoperatively
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Procedure-related complications, including arterial perforation, arterial dissection, and embolization to a new vascular territory.
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At the end of the procedure or intraoperatively
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Procedure-related complications: arterial perforation, arterial dissection, and new territorial embolism, etc
時間枠:At the end of the procedure or intraprocedurally
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Procedure-related complications: arterial perforation, arterial dissection, and new territorial embolism, etc.
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At the end of the procedure or intraprocedurally
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The rate of all-cause mortality within 1 year (± 30 days)
時間枠:1 year (±30 days) after randomization (or after enrollment)
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The rate of all-cause mortality within 1 year (±30 days).
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1 year (±30 days) after randomization (or after enrollment)
|
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The rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification or any intracranial hemorrhage within 1 year (±30 days)
時間枠: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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Feng Gao, MD、Beijing Tiantan Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2028年6月1日
試験登録日
最初に提出
2026年5月25日
QC基準を満たした最初の提出物
2026年5月25日
最初の投稿 (実際)
2026年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月1日
QC基準を満たした最後の更新が送信されました
2026年5月25日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- HX-A-2026023
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いいえ
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