NCT04748068

Brief Summary

The objective of this study is to determine the rate of early radial artery occlusion following 7-French(7-Fr) transradial coronary intervention using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 7-Fr radial sheath.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

January 25, 2021

Last Update Submit

February 8, 2021

Conditions

Radial Artery OcclusionCoronary Artery Disease

Keywords

Radial artery occlusion7-Fr radial sheathTransradial Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Radial artery occlusion

    Evaluated clinically and by ultrasound

    24 hours

Secondary Outcomes (4)

  • Vascular access site complications

    24 hours

  • Radial artery spasm

    24 hours

  • Procedure success

    24 hours

  • The degree of pain at the puncture site

    24 hours

Study Arms (2)

Glidesheath Slender

EXPERIMENTAL

The transradial procedure will be performed using the 7-Fr glidesheath slender (studied sheath)

Device: 7-Fr Glidesheath Slender

Standard sheath

ACTIVE COMPARATOR

The transradial procedure will be performed using the standard 7- French radial sheath (comparator sheath)

Device: Cordis 7-Fr radial sheath

Interventions

7-Fr Glidesheath SlenderDEVICE

The 7 Fr Glidesheath Slender is a recently developed thin-walled radial sheath. It combines an ID of 2.46 mm, with an OD of 2.79 mm, representing thereby the thinnest 7 Fr sheath currently available on the market

Also known as: Glidesheath Slender, Terumo, Tokyo, Japan
Glidesheath Slender
Cordis 7-Fr radial sheathDEVICE

Avanti+ Catheter Sheath Introducer, Cordis, USA, outer diameter: 3.02 mm

Standard sheath

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing coronary PCI via 7-Fr transradial approach
  • Informed consent
  • the patency of radial artery confirmed by ultrasound

You may not qualify if:

  • The abnormal of radial artery confirmed by ultrasound
  • Previous failed radial access.
  • Known bleeding disorder or hypercoagulable condition
  • Cardiogenic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (7)

  • Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, Ratib K, Large A, Fraser D, Nolan J, Mamas MA. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1):e002686. doi: 10.1161/JAHA.115.002686.

    PMID: 26811162BACKGROUND

  • Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.

    PMID: 31753298BACKGROUND

  • Aminian A, Iglesias JF, Van Mieghem C, Zuffi A, Ferrara A, Manih R, Dolatabadi D, Lalmand J, Saito S. First prospective multicenter experience with the 7 French Glidesheath slender for complex transradial coronary interventions. Catheter Cardiovasc Interv. 2017 May;89(6):1014-1020. doi: 10.1002/ccd.26773. Epub 2016 Aug 27.

    PMID: 27567021BACKGROUND

  • Isawa T, Horie K, Honda T, Taguri M, Tada N. Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices. J Interv Cardiol. 2020 Aug 14;2020:8216831. doi: 10.1155/2020/8216831. eCollection 2020.

    PMID: 32863791BACKGROUND

  • Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary intervention. Catheter Cardiovasc Interv. 1999 Feb;46(2):173-8. doi: 10.1002/(SICI)1522-726X(199902)46:23.0.CO;2-4.

    PMID: 10348538BACKGROUND

  • Costa F, van Leeuwen MA, Daemen J, Diletti R, Kauer F, van Geuns RJ, Ligthart J, Witberg K, Zijlstra F, Valgimigli M, Van Mieghem NM. The Rotterdam Radial Access Research: Ultrasound-Based Radial Artery Evaluation for Diagnostic and Therapeutic Coronary Procedures. Circ Cardiovasc Interv. 2016 Feb;9(2):e003129. doi: 10.1161/CIRCINTERVENTIONS.115.003129.

    PMID: 26839392BACKGROUND

  • Wang H, Wang HY, Wu SY, Yin D, Feng L, Song WH, Wang HJ, Zhu CG, Dou KF. Effect of Thin-Walled Radial Sheath for Large-Bore Access On Reducing Periprocedural Radial Artery Occlusion Following Complex PCI: The REDUCE-RAO Randomized Trial. Rev Cardiovasc Med. 2022 Sep 28;23(10):329. doi: 10.31083/j.rcm2310329. eCollection 2022 Oct.

    PMID: 39077135DERIVED

MeSH Terms

Conditions

Arterial Occlusive DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosis

Study Officials

  • Kefei Dou, MD,PhD

    Fuwai Hospital National Center for Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

  • Chenggang Zhu, MD,PhD

    Fuwai Hospital National Center for Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Wang, MD,PhD

CONTACT

+86-15701277767wanghao_fuwai@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 10, 2021

Study Start

February 1, 2021

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)