The primary objective of this study is to evaluate whether rescue stenting therapy can improve neurological functional outcomes after failed endovascular treatment for acute ischemic stroke caused by large vessel occlusion. The study population is divided into two groups: Stent Placement Group: If recanalization is not achieved after 3-5 attempts of thrombectomy, direct stent placement or balloon angioplasty is performed. Continued Thrombectomy Group: If recanalization is not achieved after 3-5 attempts of thrombectomy, at least one additional thrombectomy attempt is performed. The primary efficacy endpoint is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90±7 days. The safety endpoint is the incidence of symptomatic intracranial hemorrhage within 48 hours after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
312
For patients who fail thrombectomy, perform stent placement.
For patients with failed thrombectomy, perform at least one additional thrombectomy attempt
For patients who fail thrombectomy, perform balloon angioplasty.
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Proportion of patients with mRS 0-2
Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale(0-6), A lower MRS score indicates better functional status for the patient.
Time frame: 90±7 days
Change in NIHSS score from baseline
Change in National Institute of Health stroke scale score from baseline.The NIH Stroke Scale (NIHSS) score ranges from 0 to 42 points, with lower scores indicating better neurological function
Time frame: 36±12 hours post-randomization
Vascular recanalization rate assessed by CT/MR angiography
Vascular recanalization rate assessed by CT/MR angiography
Time frame: at 36±12 hours post-randomization
Change in infarct volume
Change in infarct volume
Time frame: at 7±3 days post-randomization or discharge (whichever comes first)
Distribution of mRS scores
Modified Rankin Scale(0-6), A lower MRS score indicates better functional status for the patient.
Time frame: 7±3 days/discharge and 90±7 days post-randomization
Proportion of patients achieving mRS 0-1
Proportion of patients achieving mRS 0-1
Time frame: 90±7 days
Incidence of rescue therapy
Incidence of rescue therapy
Time frame: 90±7 days
EQ-5D-5L utility score
The EuroQol 5-Dimension 5-Level Utility Score (EQ-5D-5L utility score) ranges from -0.594 to 1.000 (Chinese value set), assessing health-related quality of life, with higher scores indicating better health status.
Time frame: 90±7 days
Probability of symptomatic intracranial hemorrhage
Probability of symptomatic intracranial hemorrhage
Time frame: 48 hours
All-cause mortality
All-cause mortality
Time frame: 90±7 days post-randomization
Probability of any intracranial hemorrhage (per Heidelberg criteria)
Probability of any intracranial hemorrhage (per Heidelberg criteria)
Time frame: 48 hours post-randomization
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