用于治疗症状性颅内动脉粥样硬化性狭窄病变的新型脑血管药物涂层球囊导管：前瞻性、多中心、单臂、目标值临床试验研究方案

Q3 Medicine Journal of Interventional Medicine Pub Date : 2023-11-01 DOI:10.1016/j.jimed.2023.10.001

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

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引用次数: 1

摘要

背景以前的单中心研究表明，药物涂层球囊（DCB）可降低再狭窄率，而再狭窄率是影响颅内介入治疗预后的一个重要因素。然而，目前可用的心脏 DCB 并不总是适合治疗颅内动脉粥样硬化性狭窄（ICAS）。这项前瞻性、多中心、单臂、目标值临床试验在中国的9个卒中中心进行，旨在评估新型DCB导管治疗无症状重度ICAS的安全性和有效性。研究使用 SAS 9.4 版（SAS Institute，Cary，NC，USA）对主要指标和其他指标进行了收集和分析。结论本研究结果表明，标签上的新型紫杉醇 DCB 专为治疗 ICAS 而设计，具有通畅率、安全性和有效性。注册日期：2021年6月11日-前瞻性注册，https://www.chictr.org.cn/ChiCTR2100047223。

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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

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.