临床试验/NCT07646444

NCT07646444招募中不适用

OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions (OPEN-SAFE Registry)

Minneapolis Heart Institute Foundation1 个研究点分布在 1 个国家目标入组 300 人开始时间: 2026年8月1日最近更新: 2026年8月10日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Minneapolis Heart Institute Foundation
入组人数: 300
试验地点: 1
主要终点: In-Hospital Outcomes

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

The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Cross Sectional

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age 18 years or older
•Subjects who underwent a clinically indicated PCI procedure that involved at least one OPN balloon
•Date range for data collection will be from February 1, 2023 to December 31, 2028

排除标准

•Subjects who have opted out of being included in research related data collection

结局指标

主要结局

In-Hospital Outcomes

时间窗: periprocedural

Descriptive summaries of incidence of in-hospital outcomes and MACE

Treatment Utilization

时间窗: intra-procedural

descriptive summaries of various treatments utilized before and after use of the OPN balloon

Predictors of Success and Failure for the OPN Balloon

时间窗: intra-procedural

Assess predictors for failure of the OPN balloon

次要结局

未报告次要终点

研究者

发起方

Minneapolis Heart Institute Foundation

申办方类型

Other

责任方

Sponsor

研究点 (1)

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