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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 ANGEL-ICAS trial is a multicenter, prospective, randomized, open-label, blinded-endpoint study designed to determine whether rescue balloon angioplasty is noninferior to rescue stenting in patients with intracranial atherosclerosis-related acute ischemic stroke who have residual intracranial arterial stenosis of at least 50% after endovascular treatment and require additional rescue therapy. A total of 486 eligible participants will be randomly assigned in a 1:1 ratio to the balloon angioplasty group or the stenting group. In the balloon angioplasty group, rescue stenting is permitted if the angiographic result after balloon angioplasty is considered inadequate. In the stenting group, balloon angioplasty may be performed in conjunction with stent implantation when clinically indicated. Both groups will receive standard medical management according to the study protocol. The primary outcome is the proportion of participants achieving functional independence, defined as a modified Rankin Scale score of 0-2, at 90 days after randomization. Key safety outcomes include symptomatic intracranial hemorrhage within 48 hours, any intracranial hemorrhage within 48 hours, and all-cause mortality at 90 days
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
486
Start Date
2025-07-03
Completion Date
2027-07-01
Last Updated
2026-09-03
Healthy Volunteers
No
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, Capital Medical University
Beijing, Beijing Municipality, China