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OpenTrials
Completed

NCT Number: NCT07218406

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terumo Glidesheath Slender sheath

Device

Terumo Glidesheath Slender sheath in the radial artery

Merit Prelude Ideal sheath

Device

Merit Prelude Ideal sheath in the radial artery

Primary outcomes

  1. Physicians satisfaction score

    Time frame: 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 outcomes

  1. Requirement of a skin nick to advance the sheath (yes/no)

    Time frame: Within one day of procedure

    Outcome measure is assessed by the Qualitative survey of physician satisfaction. Binary outcome of yes or no

  2. Presence of leakage from the sheath's hemostatic valve during the procedure (yes/no)

    Time frame: 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

  3. Number of cases with radial artery spasm

    Time frame: Within one day of procedure

    Outcome measure is assessed by the Qualitative survey of physician satisfaction.

  4. Number of cases with patient reported forearm pain

    Time frame: Within one day of procedure

    Outcome measure is assessed by the Qualitative survey of physician satisfaction.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 20, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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