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

NYU Langone Health logo

NYU Langone Health

Status

Not yet enrolling

Conditions

Transradial Access

Treatments

Device: Merit Prelude Ideal sheath
Device: Terumo Glidesheath Slender sheath

Study type

Observational

Funder types

Other

Identifiers

NCT07218406
QI-Radial Artery Sheaths

Details and patient eligibility

About

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

Full 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).

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Terumo Glidesheath Slender sheath
Description:
Physicians will use the Terumo Glidesheath Slender sheath during the procedure.
Treatment:
Device: Terumo Glidesheath Slender sheath
Merit Prelude Ideal sheath
Description:
Physicians will use the Merit Prelude Ideal sheath during the procedure.
Treatment:
Device: Merit Prelude Ideal sheath

Trial contacts and locations

1

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Central trial contact

Sunil Rao, MD

Data sourced from clinicaltrials.gov

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