Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis

Summary

Intracranial atherosclerotic disease (ICAD) is the most common cause of ischemical cerebrovascular events. The risk of stroke recurrence or death of ICAD patients remains very high. Even with aggressive medical management including dual antiplatelet therapy and strict management of risk factors, 12.2 percent of patients with 70-99 percent stenosis of intracranial artery had stroke or death during 1 year follow-up. In the real world, the 30-day risk of recurrent stroke of patients with aggressive medical management was as high as 20.2 percent. Balloon angioplasty and stent for intracranial artery have become important alternative treatments to prevent recurrent stroke for patients with severe intracranial atherosclerotic stenosis. Nevertheless, the SAMMPRIS trial has suggested intracranial stenting has higher stroke and death rate than aggressive medication with high peri-procedure complication rate. Previous nonrandomized studies have showed that stroke and death rate of angioplasty for ICAD patients with severe stenosis of intracranial artery is lower than that of aggressive medication. The primary purpose of this trial is to compare intracranial angioplasty plus aggressive medical management with aggressive medical management alone for the treatment of patients with 70-99 percent intracranial artery stenosis because of ICAD and to clarify the efficacy and safety of intracranial angioplasty through a multicenter, prospective, randomized, open-label, blinded end-point trial.

Timeline

Start

2018-10-17

Primary completion

2023-05-02

Completion

2025-05

Publications

• Sun X, Deng Y, Zhang Y, Yang M, Sun D, Nguyen TN, Tong X, Peng G, Liu A, Xu Y, Wu Y, Geng X, Wang Y, Li T, Xing S, Wu W, Ji Y, Yang H, Wang S, Gao X, Yang W, Zhao X, Liu L, Ma N, Gao F, Mo D, Huo X, Song L, Li X, Zhang J, He H, Lv M, Mu S, Yu W, Liebeskind DS, Amin-Hanjani S, Wang Y, Wang Y, Miao Z; BASIS Investigators. Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis: The BASIS Randomized Clinical Trial. JAMA. 2024 Oct 1;332(13):1059-1069. doi: 10.1001/jama.2024.12829.
• Sun X, Yang M, Sun D, Peng G, Deng Y, Zhao X, Liu L, Ma N, Gao F, Mo D, Yu W, Wang Y, Wang Y, Miao Z. Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS): protocol of a prospective, multicentre, randomised, controlled trial. Stroke Vasc Neurol. 2024 Feb 27;9(1):66-74. doi: 10.1136/svn-2022-002288.

Drugs

Indications