跳至主要内容
临床试验/NCT00489320
NCT00489320已完成不适用

An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).

Cordis Corporation1 个研究点 分布在 1 个国家目标入组 7,759 人开始时间: 2004年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7,759
试验地点
1

研究概览

简要总结

The DEScover Registry is designed to observe the results of using Drug Eluting Stents (DES) in patients in a real-world setting. The stents being observed are not investigational, that is, they have been approved for use in the general population.

详细描述

The D.E.S.cover Registry is a prospective, multi-center, observational study. Consecutive patients undergoing PCI procedures will be asked to consent to participate in this study. For these patients, baseline, clinical and angiographic characteristics, as well as certain procedural and clinical events will be recorded using standardized case report forms. Outcomes will be assessed during hospitalization and at one, six and twelve months after discharge. Depending on results from the first year of follow-up, the study may be extended with an additional one or two years of follow-up.

The strategy for achieving the scientific objectives of the Registry is to document actual, real-world PCI practice and outcomes. Accordingly, the D.E.S.cover Registry does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the D.E.S.cover Registry database.

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Consecutive patients undergoing percutaneous coronary intervention at an enrolling center by study investigators

排除标准

  • Patient refusal or inability to provide written informed consent and/or HIPAA authorization

研究者

申办方类型
Industry

研究点 (1)

Loading locations...

相似试验