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

适应症

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: 2
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

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 (2)

Loading locations...

相似试验

Unknown

4 期

Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimenCoronary Heart Disease

NCT01267734Seoul National University Hospital3,750

已完成

不适用

Vascular Implant Safety and Efficacy StudyCoronary Artery Disease

NCT03263858Biotronik CRC Inc.66

Unknown

2 期

Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary StentCoronary Artery DiseaseMyocardial Ischemia

NCT02189499Amaranth Medical Inc.42

已完成

不适用

Evaluation of Long Coronary Artery Stents With Third-generation Dual-source Computed Tomography AngiographyChronic Total Occlusion of Coronary ArteryCoronary Artery Disease

NCT06543641Lauri Mansikkaniemi45

已完成

3 期

Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)Carotid Artery Disease

NCT00231270Cordis US Corp.1,300