Efficacy and Safety of Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Intracranial Atherosclerotic Large Vessel Occlusion (ANGEL-REBOOT 2)
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
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
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
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100070
- Beijing Tiantan Hospital, Capital Medical University
-
-
参加基準
適格基準
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
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
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
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的: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).
|
|
他の: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).
|
この研究は何を測定していますか?
主要な結果の測定
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)
|
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)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
|
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
時間枠: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
時間枠: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
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.
|
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
時間枠: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
時間枠: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)
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).
|
1 year (±30 days) after randomization (or after enrollment)
|
|
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)
|
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
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.
|
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)
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.
|
1 year (±30 days) after randomization (or after enrollment)
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
|
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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
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
捜査官
捜査官
- 主任研究者:Feng Gao, MD、Beijing Tiantan Hospital
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
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
その他の研究ID番号
- HX-A-2026023
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。