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Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke
Sponsor: Beijing Anzhen Hospital
Summary
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.
Official title: Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
322
Start Date
2025-07-03
Completion Date
2027-06-01
Last Updated
2025-08-13
Healthy Volunteers
No
Conditions
Interventions
balloon angioplasty
Balloon angioplasty treatment followed by standard medical therapy post-procedure.
Stent
Patients will receive either balloon-assisted stenting or direct stenting, followed by standard medical therapy after the endovascular treatment.
Locations (1)
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China