临床试验/NCT00799032

NCT00799032已完成1 期

Assessment of The Latest Non-Thrombogenic Angioplasty Stent (ATLANTA): Prospective, First in Man, Non-Randomized, Single Center for Patients With Documented Myocardial Ischemia Undergoing PCI

CeloNova BioSciences, Inc.1 个研究点分布在 1 个国家目标入组 55 人开始时间: 2007年5月1日最近更新: 2017年6月7日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: CeloNova BioSciences, Inc.
入组人数: 55
试验地点: 1
主要终点: Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the short-term and mid-term safety and efficacy of the Catania coronary stent for the treatment of up to two de novo lesions in native coronary arteries.

详细描述

This is a prospective, non-randomized, first-in-man single center study. The study requires a 55 patients with documented myocardial ischemia undergoing PCI.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 30 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Lesion length ≤ 20 mm
•Vessel size ≥ 2.5 ≤ 3.5 mm

排除标准

•Life expectancy < 1 year
•Left ventricular ejection fraction (LVEF) <30%
•Anti-thrombotic drug intolerance

研究组 & 干预措施

Stent

Other

Catania Stent

干预措施: PCI (Device)

结局指标

主要结局

Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI

时间窗: In Hospital

次要结局

Any death, cardiac death, stent related fatal / non fatal Myocardial Infarction, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Binary Restenosis(1 and 6 months)

研究者

发起方

CeloNova BioSciences, Inc.

申办方类型

Industry

研究点 (1)

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