Multi-center prospective trial with external control of Sirolimus Eluting Stent System (NP024)

NIPRO CORPORATION1 个研究点目标入组 334 人开始时间: 待定最近更新: 2020年10月7日

试验速览

阶段: 3 期
状态: 已完成
发起方: NIPRO CORPORATION
入组人数: 334
试验地点: 1
主要终点: Freedom from Target Lesion Failure (TLF)

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

暂无简介。

研究设计

研究类型: Interventional
干预模型: Multicenter, Non-randomized clinical trial with external control
主要目的: Treatment Purpose

入排标准

年龄范围: 20age old over 至 No limit（—）
性别: All

入选标准

•Clinical inclusion criteria
•Patient with stable or unstable angina pectoris or documented silent ischemia
•Patient is eligible for percutaneous coronary intervention
•Patient is acceptable candidate for CABG
•Angiographic inclusion criteria (by visual estimation)
•Native coronary artery
•De novo lesion
•The stenosis of target lesion is 50% or more to less than 100%
•Target vessel diameter is 2.5 mm to 4.25 mm

排除标准

•Clinical exclusion criteria
•Known allergy to L-605 CoCr alloy (cobalt, chromium, nickel, tungsten)
•Not a suitable candidate for DAPT
•Known allergy to contrast agent
•LVEF of the patient is not more than 30%
•Renal dysfunction (Creatinine value exceeds 2.0 mg/dl or in case artificial dialysis)
•AMI within 72 hours before baseline procedure.
•Female of child-bearing potential
•Currently participating in an investigational drug or device study
•In cases where the Investigator determines that the patient's participation in the trial is inappropriate
•Angiographic exclusion criteria
•Within 9 months after implementing PCI on the target vessel or its branch
•Lesion in left main coronary trunk
•Lesion within 3 mm from the ostium right coronary artery
•Lesion within 2 mm from the ostium left anterior descending/the ostium left circumflex branch
•Bifurcation lesion that need stenting of main and side branch
•Total occlusion

结局指标

主要结局

Freedom from Target Lesion Failure (TLF)

时间窗: 9 months post stent implantation

a device oriented composite endpoint (cardiac death and MI not clearly attributable to a non-target vessel, and clinically driven Target Lesion Revascularization (TLR))

次要结局

未报告次要终点

研究者

发起方

NIPRO CORPORATION

研究点 (1)

Loading locations...

相似试验

已完成

3 期

NP028 clinical trial

jRCT1080224100NIPRO CORPORATION207

已完成

3 期

NP030 clinical trial

jRCT2080224719NIPRO CORPORATION312

进行中（未招募）

不适用

Study about the high flow and conventional oxigen therapy in patients with severe acute respiratory failure.

EUCTR2012-001671-36-ESFundación para la Investigación Biomédica

进行中（未招募）

1 期

Phase 4 clinical trial to evaluate the effect on immune recovery of antiretroviral treatment of three drugs versus two in in HIV-infected patients but not dectactable in blood.Adult patients with HIV infection on stable therapy (= 6 months) with triple therapy and undetectable viremia for = 1 year.MedDRA version: 19.1Level: LLTClassification code 10049838Term: HIV viral load undetectableSystem Organ Class: 100000004848MedDRA version: 19.1Level: PTClassification code 10077716Term: HIV viraemiaSystem Organ Class: 10021881 - Infections and infestations

EUCTR2016-005226-11-ESFundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)180

尚未招募

4 期

Efficacy of analgesics in controlling pain associated with the insertion of a Copper or Hormone Intrauterine DevicePelvic and perineal painInsertion of contraceptive device (intrauterine)R52.0

RBR-7phn8yvHospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp