GORE药物涂层PTA球囊导管用于CE标志批准的临床研究
该数据集包含GORE药物涂层球囊导管治疗外周动脉疾病股腘动脉病变的临床试验数据，包括6个月晚期管腔丢失和30天主要不良事件等终点结果。
基本信息
资源简介
GORE药物涂层PTA球囊导管用于CE标志批准的临床研究
【一句话概览】
本数据集是 figshare 公开的结构化表格数据集，收录 1 个文件、合计 19.79 KB，主题涵盖 Balloon angioplasty、drug-coated balloon、superficial femoral artery、paclitaxel、popliteal artery，可用于统计建模、特征工程与队列分析，CC BY 4.0 许可开放获取。
【数据集背景】
本数据集源站标题为《Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval》。配套论文《Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval》发表于 Expert Review of Medical Devices（2023），DOI：10.1080/17434440.2023.2214679。项目资助方：This paper was not funded.。源站首次发布：2023-05-16。
【数据内容】
源站原始描述：Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval. Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (o…
【数据结构与技术规格】
文件数 1 个，合计 19.79 KB。ierd_a_2214679_sm8265.odt：application/vnd.oasis.opendocument.text，19.79 KB。数据集 DOI：10.6084/m9.figshare.22843714.v1。
【主题与分类】
源站学科分类：Space Science、Medicine、Pharmacology、Biological Sciences not elsewhere classified。主题标签：Balloon angioplasty、drug-coated balloon、superficial femoral artery、paclitaxel、popliteal artery、peripheral artery disease、ePTFE。
【适用方向】
结构化表格数据可直接用于统计建模、特征工程与队列分析。
【获取与许可】
源站页面：https://tandf.figshare.com/articles/dataset/Clinical_investigation_of_the_GORE_drug-coated_PTA_balloon_catheter_for_CE_mark_approval/22843714
使用许可：CC BY 4.0（https://creativecommons.org/licenses/by/4.0/）。
规范引用：Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval. Taylor & Francis. Noory, Elias; Tepe, Gunnar; Piorkowski, Michael; Thieme, Marcus; Müller-Hülsbeck, Stefan; Brechtel, Klaus; et al
【使用注意】
· 源站最后修改于 2023-06-14，引用时请注意版本时效。
下载信息
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使用方式
数据集获取（Figshare）
- 源站标题：Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval
- DOI：10.6084/m9.figshare.22843714.v1
- 发布日期：2023-05-16
- 文件数：1 个
- 文件总体积：19.79 KB
- 源站页面：https://tandf.figshare.com/articles/dataset/Clinical_investigation_of_the_GORE_drug-coated_PTA_balloon_catheter_for_CE_mark_approval/22843714
命令行下载
curl -L -o "ierd_a_2214679_sm8265.odt" "https://ndownloader.figshare.com/files/40593829"
文件清单
ierd_a_2214679_sm8265.odt（19.79 KB）
文件总体积 19.79 KB（源站 API 实测）。
数据说明
Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval.
Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 μg/mm2) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE).
Fifty-two subjects were enrolled, 69% men, median age 69 (49–83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (−0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively.
The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.
许可
CC BY 4.0
引用
学术使用请引用 DOI 10.6084/m9.figshare.22843714.v1（source: https://tandf.figshare.com/articles/dataset/Clinical_investigation_of_the_GORE_drug-coated_PTA_balloon_catheter_for_CE_mark_approval/22843714）。
数据缺失？
依托陕西、四川两大基地，我们与超过十家三甲医院建立直接合作关系，覆盖合规授权、采集治理、专业标注、数据交付的全流程，为AI医疗团队提供即拿即用的高质量临床数据。
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