NCT07026331

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 322 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-03
• Primary completion: 2027-04-01
• Completion: 2027-06-01
• First posted: 2025-06-18
• Last updated: 2025-08-13

Locations

1 site across 1 country: China