A novel cerebrovascular drug-coated balloon catheter for treating symptomatic intracranial atherosclerotic stenosis lesions: Study protocol for a prospective, multicenter, single-arm, target-value clinical trial

Qianhao Ding; Wenbo Liu; Jingge Zhao; Dehua Guo; Yao Tang; Tengfei Zhou; Yanyan He; Ferdinand K Hui; Yonghong Ding; Liangfu Zhu; Zilang Wang; Yingkun He; Tianxiao Li

doi:10.1016/j.jimed.2023.10.001

A novel cerebrovascular drug-coated balloon catheter for treating symptomatic intracranial atherosclerotic stenosis lesions: Study protocol for a prospective, multicenter, single-arm, target-value clinical trial

J Interv Med. 2023 Oct 27;6(4):180-186. doi: 10.1016/j.jimed.2023.10.001. eCollection 2023 Nov.

Authors

Affiliations

¹ Department of Cerebrovascular Disease and Neurosurgery, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, 450003, China.
² Clinical Research Center, Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Zhengzhou, 450003, China.
³ Neuroscience Institute, Queen's Medical Center, University of Hawaii, Honolulu, HI, USA.
⁴ Department of Radiology, Mayo Clinic, Rochester, MN, USA.

Abstract

Background: Previous single-center studies have demonstrated that drug-coated balloons (DCBs) may reduce restenosis rates, which is an important factor affecting the prognosis for intracranial interventional therapy. However, currently available cardiac DCBs are not always suitable for the treatment of intracranial atherosclerotic stenosis (ICAS). This study aimed to evaluate the safety and efficacy of a novel DCB catheter designed for patients with severely symptomatic ICAS.

Methods: This prospective, multicenter, single-arm, target-value clinical trial was conducted in 9 Chinese stroke centers to evaluate the safety and efficacy of a novel DCB catheter for treating symptomatic severe ICAS. Primary metrics and other indicators were collected and analyzed using SAS version 9.4 (SAS Institute, Cary, NC, USA).

Results: A total of 155 patients were enrolled in this study. The preliminary collection of follow-up data has been completed, while data quality control is ongoing.

Conclusion: Results of this study demonstrated the patency rate, safety, and effectiveness of a novel on-label paclitaxel DCB designed for the treatment of ICAS.

Trial registration: ChiCTR, ChiCTR2100047223. Registered June 11, 2021-Prospective registration, https://www.chictr.org.cn/ChiCTR2100047223.

Keywords: Drug-coated balloon; Endovascular therapy; Intracranial arterial stenosis; Ischemic stroke; Transient ischemic attack.