Transradial AccessNCT07218406
Comparison of Merit Prelude Ideal and Terumo Glidesheath Slender Radial Artery Sheaths
An observational study of Transradial Access, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transradial Access
- What is being tested?
- Terumo Glidesheath Slender sheath and Merit Prelude Ideal sheath
- Type of treatment
- Medical device
- How many people
- 554 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Physicians within the NYU Cardiac Catheterization Laboratory
Who may be able to join
- 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.
Who cannot join
- No plan for at least one radial artery access
- Physician preference to not participate
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine physician preference of sheath type based on a qualitative survey utilizing an EPIC-based randomization platform.
Read the 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
- Being tested
- Terumo Glidesheath Slender sheath, Merit Prelude Ideal sheath
- Keywords
- transradial access, randomized trial, pragmatic EMR-based trial, TRA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terumo Glidesheath Slender sheathDevice
Terumo Glidesheath Slender sheath in the radial artery
Merit Prelude Ideal sheathDevice
Merit Prelude Ideal sheath in the radial artery
| Study group | Role | What they receive |
|---|---|---|
| Terumo Glidesheath Slender sheath | Physicians will use the Terumo Glidesheath Slender sheath during the procedure. Receives: Device: Terumo Glidesheath Slender sheath | |
| Merit Prelude Ideal sheath | Physicians will use the Merit Prelude Ideal sheath during the procedure. Receives: Device: Merit Prelude Ideal sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one day of procedure
Secondary outcomes (4)
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
Measured: Within one day of procedure
Presence of leakage from the sheath's hemostatic valve during the procedure (yes/no)
Outcome measure is assessed by the Qualitative survey of physician satisfaction. Binary outcome of yes or no based on qualitative survey
Measured: Within one day of procedure
Number of cases with radial artery spasm
Outcome measure is assessed by the Qualitative survey of physician satisfaction.
Measured: Within one day of procedure
Number of cases with patient reported forearm pain
Outcome measure is assessed by the Qualitative survey of physician satisfaction.
Measured: Within one day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start20 Oct 2025
- Primary completion25 Nov 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transradial AccessStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunil Rao, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218406
- Sponsor's protocol ID
- QI-Radial Artery Sheaths
- Status last verified
- Apr 2026
- First submitted
- 14 Oct 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 42106091
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Merit Prelude Ideal and Terumo Glidesheath Slender Radial Artery Sheaths
- ClinicalTrials.gov ID
- NCT07218406
- Acronym / sponsor ID
- QI-Radial Artery Sheaths
- Conditions
- Transradial Access
- Keywords
- transradial access, randomized trial, pragmatic EMR-based trial, TRA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terumo Glidesheath Slender sheath | – | Device: Terumo Glidesheath Slender sheathPhysicians will use the Terumo Glidesheath Slender sheath during the procedure. |
| Merit Prelude Ideal sheath | – | Device: Merit Prelude Ideal sheathPhysicians will use the Merit Prelude Ideal sheath during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians within the NYU Cardiac Catheterization Laboratory
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- No plan for at least one radial artery access
- Physician preference to not participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terumo Glidesheath Slender sheathTerumo Glidesheath Slender sheath in the radial artery | Device | Terumo Glidesheath Slender sheath |
| Merit Prelude Ideal sheathMerit Prelude Ideal sheath in the radial artery | Device | Merit Prelude Ideal sheath |
Primary outcome
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.
4 secondary outcomes
Requirement of a skin nick to advance the sheath (yes/no)
Time frame: Within one day of procedure
Presence of leakage from the sheath's hemostatic valve during the procedure (yes/no)
Time frame: Within one day of procedure
Number of cases with radial artery spasm
Time frame: Within one day of procedure
Number of cases with patient reported forearm pain
Time frame: Within one day of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Derived from this study: PubMed 42106091Shah 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Rao, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transradial Access, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physicians satisfaction score (time frame: Within one day of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07218406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.