当前位置: 首页 > 详情页

First-in-Man Study of a Novel Peripheral Plaque Atherectomy Device

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE

机构: [1]Capital Med Univ, Xuanwu Hosp, Dept Vasc Surg, Beijing, Peoples R China
出处:
ISSN:

关键词: atherectomy endovascular FIM lower extremity atherosclerosis disease peripheral arterial disease

摘要:
This first-in-man (FIM) study evaluated the feasibility and safety of a new peripheral plaque atherectomy system in patients with symptomatic lower extremity artery disease (LEAD). Ten patients with symptomatic LEAD (Rutherford class 2-5) were enrolled in a prospective, single-center study from March to April 2024. Patients aged 18-85 years with target lesions showing >= 70% stenosis and reference vessel diameters >= 1.8 mm underwent treatment using a novel atherectomy device with a "shaving" mechanism to excise calcified plaques. Outcomes included post-procedural stenosis improvement, 6-month primary patency rate, and safety endpoints such as thrombosis, vasospasm, acute occlusion, and distal embolization. Statistical analysis used SPSS 23.0. Ten male patients (mean age: 61.4 +/- 9.2 years) were treated. Most had diabetes (80%), hypertension (70%), and hyperlipidemia (80%). Pre-procedural ankle-brachial index (ABI) averaged 0.50 +/- 0.14. Angiographic analysis showed 60% of lesions in the femoral artery and 40% as chronic total occlusions. No major adverse events occurred, with 100% technical success. Post-procedural ABI improved to 0.92 +/- 0.12 (p < 0.05). At 6 months, the primary patency rate was 100%, with no clinically-driven revascularization or adverse cardiovascular events. Mortality was 0%. All patients reported significant improvement in symptoms and walking distance, as well as enhanced quality of life and reduced pain during physical activity. The novel atherectomy device showed promising safety and efficacy for treating calcified LEAD. Larger-scale trials are needed to confirm these outcomes.

基金:
语种:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2024]版:
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 外周血管病
JCR分区:
出版当年[2023]版:
Q2 PERIPHERAL VASCULAR DISEASE
最新[2023]版:
Q2 PERIPHERAL VASCULAR DISEASE

影响因子: 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者:
第一作者机构: [1]Capital Med Univ, Xuanwu Hosp, Dept Vasc Surg, Beijing, Peoples R China
通讯作者:
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:16936 今日访问量:0 总访问量:903 更新日期:2025-03-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 首都医科大学宣武医院 技术支持:重庆聚合科技有限公司 地址:北京市西城区长椿街45号宣武医院