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临床试验/NCT07218406
NCT07218406已完成不适用

Comparison of Merit Prelude Ideal and Terumo Glidesheath Slender Radial Artery Sheaths

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 554 人开始时间: 2025年10月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
554
试验地点
1
主要终点
Physicians satisfaction score

研究概览

简要总结

The aim of this study is to determine physician preference of sheath type based on a qualitative survey utilizing an EPIC-based randomization platform.

详细描述

Physician's with patients undergoing diagnostic coronary angiography or percutaneous coronary intervention (PCI) via a planned radial artery access approach will be randomized to either the Terumo Glidesheath Slender or Merit Prelude Ideal radial artery sheath via an electronic medical record (EMR) (EPIC)-based randomization that will be conducted automatically prior to the procedure. The nursing team will set up the room as per usual and include the sheath that was identified in the randomization process. Physician's will complete the diagnostic coronary angiography and/or PCI per usual standard of care. Physicians will complete the questionnaire regarding their preferences at the end of the case. With the exception of the physician survey, the data to be reviewed will already exist as part of the standard EMR documentation. Datacore analysts will retrieve data of patients randomized from the EMR and populate in a database for analysis using a unique identifier that does not link the patients to their identifiable information (i.e. de-identified).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Physician has patient(s) undergoing diagnostic coronary angiography or percutaneous coronary intervention (PCI) across the NYU Langone Health enterprise will be eligible for the study.

排除标准

  • No plan for at least one radial artery access
  • Physician preference to not participate

研究组 & 干预措施

Terumo Glidesheath Slender sheath

Physicians will use the Terumo Glidesheath Slender sheath during the procedure.

干预措施: Terumo Glidesheath Slender sheath (Device)

Merit Prelude Ideal sheath

Physicians will use the Merit Prelude Ideal sheath during the procedure.

干预措施: Merit Prelude Ideal sheath (Device)

结局指标

主要结局

Physicians satisfaction score

时间窗: Within one day of procedure

Outcome measure is assessed by the Qualitative survey of physician satisfaction. The survey asks physicians to rate 6 items from 1 being the worst (very bad) to 5 being the best (very good) about the radial artery sheath used in their case. Total scores range from 6-30, with higher scores indicating greater satisfaction with the device.

次要结局

  • Requirement of a skin nick to advance the sheath (yes/no)(Within one day of procedure)
  • Presence of leakage from the sheath's hemostatic valve during the procedure (yes/no)(Within one day of procedure)
  • Number of cases with patient reported forearm pain(Within one day of procedure)
  • Number of cases with radial artery spasm(Within one day of procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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