NCT06014723

Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA

Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 416 (estimated)
• Sponsor: Shouchun Wang, MD, PhD · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: —

Summary

The objective of this study was to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke/transient ischemic attack with intracranial atherosclerosis etiology.

Detailed description

In this study, 416 patients with minor strokes or transient ischemic attacks due to symptomatic intracranial atherosclerotic stenosis within one week of the onset of last ischemic symptoms from 20 centers in China were enrolled. The observation group received early submaximal balloon angioplasty, while the control group received only medical therapy. Two groups will be followed up for 1 year to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke / transient ischemic attack with intracranial atherosclerosis etiology.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
PROCEDURE	Submaximal balloon angioplasty	The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.

Timeline

• Start date: 2023-08-23
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2023-08-28
• Last updated: 2024-01-03

Locations

1 site across 1 country: China