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The aim of this study is to determine physician preference of sheath type based on a qualitative survey utilizing an EPIC-based randomization platform.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terumo Glidesheath Slender sheath | Physicians will use the Terumo Glidesheath Slender sheath during the procedure. |
| |
| Merit Prelude Ideal sheath | Physicians will use the Merit Prelude Ideal sheath during the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terumo Glidesheath Slender sheath | Device | Terumo Glidesheath Slender sheath in the radial artery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Requirement of a skin nick to advance the sheath (yes/no) | Outcome measure is assessed by the Qualitative survey of physician satisfaction. Binary outcome of yes or no | Within one day of procedure |
| Presence of leakage from the sheath's hemostatic valve during the procedure (yes/no) |
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Inclusion Criteria:
Exclusion Criteria:
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Physicians within the NYU Cardiac Catheterization Laboratory
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Rao, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42106091 | Derived | Shah B, Lerner J, Martin J, Patrick Crane B 4th, Andrade O, Li X, Xia Y, Yu C, Testa PA, Rao SV; Pragmatic Randomization Integrated into the Medial Record (PRIME) Investigators. Design and rationale of the Radial Access Insertion Sheath Evaluation via the electronic medical record (RAISE-EMR) study. Am Heart J. 2026 Sep;299:107476. doi: 10.1016/j.ahj.2026.107476. Epub 2026 May 7. |
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This is a quality improvement (QI) project under the institution's quality improvement oversight committee and individual participant data (IPD) will not be shared with other researchers.
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| Merit Prelude Ideal sheath | Device | Merit Prelude Ideal sheath in the radial artery |
|
Outcome measure is assessed by the Qualitative survey of physician satisfaction. Binary outcome of yes or no based on qualitative survey |
| Within one day of procedure |
| Number of cases with radial artery spasm | Outcome measure is assessed by the Qualitative survey of physician satisfaction. | Within one day of procedure |
| Number of cases with patient reported forearm pain | Outcome measure is assessed by the Qualitative survey of physician satisfaction. | Within one day of procedure |