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

NCT07218406 | Completed FDA Device

• 1 other identifier: QI-Radial Artery Sheaths
• Study Type: observational
• Target: 554
• Locations: 1 country
• Sites: 1

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.

Conditions

Transradial Access

Keywords

transradial access; randomized trial; pragmatic EMR-based trial; TRA

Outcome Measures

Primary Outcomes (1)

• Physicians satisfaction score

  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.

  Within one day of procedure

Secondary Outcomes (4)

• 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 radial artery spasm

  Within one day of procedure

• Number of cases with patient reported forearm pain

  Within one day of procedure

Study Arms (2)

Terumo Glidesheath Slender sheath

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

Device: Terumo Glidesheath Slender sheath

Merit Prelude Ideal sheath

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

Device: Merit Prelude Ideal sheath

Interventions

Terumo Glidesheath Slender sheath DEVICE

Terumo Glidesheath Slender sheath in the radial artery

Terumo Glidesheath Slender sheath

Merit Prelude Ideal sheath DEVICE

Merit Prelude Ideal sheath in the radial artery

Merit Prelude Ideal sheath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Physicians within the NYU Cardiac Catheterization Laboratory

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Sunil Rao, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 20, 2025
• Study Start: October 20, 2025
• Primary Completion: November 25, 2025
• Study Completion: April 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)