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

Not yet recruiting

• Conditions: Transradial Access

• Registration Number: NCT07218406
• Lead Sponsor: NYU Langone Health

Brief Summary

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

Detailed Description

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).

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-14
• Study First Submitted QC: 2025-10-16
• Last Update Submitted: 2025-10-16
• Study Start: 2025-10-20
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20
• Primary Completion: 2026-05-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physicians satisfaction score	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.

Secondary Outcome Measures

Name	Time	Method
Requirement of a skin nick to advance the sheath (yes/no)	Within one day of procedure	Outcome measure is assessed by the Qualitative survey of physician satisfaction. Binary outcome of yes or no
Presence of leakage from the sheath's hemostatic valve during the procedure (yes/no)	Within one day of procedure	Outcome measure is assessed by the Qualitative survey of physician satisfaction. Binary outcome of yes or no based on qualitative survey
Number of cases with patient reported forearm pain	Within one day of procedure	Outcome measure is assessed by the Qualitative survey of physician satisfaction.
Number of cases with radial artery spasm	Within one day of procedure	Outcome measure is assessed by the Qualitative survey of physician satisfaction.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States