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.
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.
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..
Parallel
Bailout Intracranial Angioplasty or Stenting
Procedure/SurgeryBalloon 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).
Standard Thrombectomy
Procedure/SurgeryEndovascular 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).
The primary endpoint is the mRS score at 90 (±7) days after randomization (or after enrollment), analyzed as an ordinal variable
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.
The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days
The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days.
The rate of stroke recurrence in the target vessel territory within 90 (±7) days
Stroke recurrence in the target vessel territory within 90 (±7) days.
NIHSS score at 24 (±6/+12) hours
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 90±7 days
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.
The rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 24 hours
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.
The rate of all-cause mortality within 90 days
All cause of mortality within 90 days.
The rate of any intracranial hemorrhage identified by CT or MRI imaging within 24 hours after randomization
Any intracranial hemorrhage identified by CT or MRI imaging within 24 (-6/+12) hours after randomization.
Procedure-related complications, including arterial perforation, arterial dissection, and embolization to a new vascular territory
Procedure-related complications, including arterial perforation, arterial dissection, and embolization to a new vascular territory.
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Feng Gao
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
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