- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07618052
Efficacy and Safety of Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Intracranial Atherosclerotic Large Vessel Occlusion (ANGEL-REBOOT 2)
25. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
420
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Feng Gao, MD
- Telefonní číslo: 13581936066
- E-mail: gaofengletter@sina.com
Studijní místa
-
-
Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100070
- Beijing Tiantan Hospital, Capital Medical University
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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).
|
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Jiný: 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).
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The primary endpoint is the mRS score at 90 (±7) days after randomization (or after enrollment), analyzed as an ordinal variable
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 24 hours
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Feng Gao, MD, Beijing Tiantan Hospital
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
1. června 2027
Dokončení studie (Odhadovaný)
1. června 2028
Termíny zápisu do studia
První předloženo
25. května 2026
První předloženo, které splnilo kritéria kontroly kvality
25. května 2026
První zveřejněno (Aktuální)
1. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
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