The primary objective of this study is to evaluate whether rescue balloon angioplasty versus stenting for residual stenosis following endovascular therapy improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized into two groups: the balloon angioplasty group receiving balloon treatment alone followed by standard medical therapy, and the stent group receiving stenting treatment with post-procedural standard medical therapy. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhage occurring within 48 hours after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
322
Balloon angioplasty treatment followed by standard medical therapy post-procedure.
Patients will receive either balloon-assisted stenting or direct stenting, followed by standard medical therapy after the endovascular treatment.
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
Vascular recanalization rate assessed by CT/MR angiography
Vascular recanalization rate assessed by CT/MR angiography
Time frame: 36±12 hours post-randomization
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
Change in infarct volume
Change in infarct volume
Time frame: 7±3 days post-randomization or discharge
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; 90±7 days post-randomization
Proportion of patients achieving mRS 0-1
Proportion of patients achieving mRS 0-1, Modified Rankin Scale(0-6), A lower MRS score indicates better functional status for the patient.
Time frame: 90±7 days
Proportion of patients achieving mRS 0-3
Proportion of patients achieving mRS 0-3
Time frame: 90±7 days
Incidence of Pharmacologic rescue therapy
Incidence of Pharmacologic rescue therapy
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
Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage (Heidelberg Standards)
Time frame: 48 hours
All-cause mortality
All-cause mortality
Time frame: 90±7 days
Probability of any intracranial hemorrhage
Probability of any intracranial hemorrhage (Heidelberg Standards)
Time frame: 48 hours post-randomization
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