Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
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 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

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, Capital Medical University

Beijing, Beijing Municipality, China