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ACTIVE NOT RECRUITING
NCT07026331
NA

Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

balloon angioplasty

Balloon angioplasty treatment followed by standard medical therapy post-procedure.

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