NCT07218406

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 554 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Transradial Access

Interventions

Type	Name	Description
DEVICE	Terumo Glidesheath Slender sheath	Terumo Glidesheath Slender sheath in the radial artery
DEVICE	Merit Prelude Ideal sheath	Merit Prelude Ideal sheath in the radial artery

Timeline

• Start date: 2025-10-20
• Primary completion: 2025-11-25
• Completion: 2026-04-01
• First posted: 2025-10-20
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study