Use of Glidesheath Slender to Reduce Radial Artery Occlusion Following 7 French Transradial Coronary Intervention

NCT ID: NCT04748068

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-05-31

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.

Detailed Description

Based on previously reported studies the rates of radial artery occlusion using a standard 7-Fr sheath is around 12%, compared to the previous studies of the Glidesheath Slender (see reference in the citations), the rate of radial artery occlusion was reported less than 5%. To prove Slender sheaths are superior to traditional ones, the sample size was estimated according to this, the class I error (α) is set as 0.05 on both sides, and the test efficiency (β) is set as 80%, then at least 248 patients are needed in each group.

This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion between the 7-Fr Glidesheath Slender (Terumo, Japan) and the standard 7-Fr radial sheath (cordis, USA) in patients undergoing complex transradial coronary intervention.

The study will enroll patients who will undergo elective complex percutaneous coronary intervention (PCI) via 7-Fr transradial approach at Fuwai Hospital National Center for Cardiovascular Diseases.

A baseline clinical vascular & ultrasound assessment will be performed prior to the procedure to document patency of the radial artery.

Patients will be randomized in 1:1 fashion to either receive the 7-Fr Terumo Glidesheath Slender versus the currently used 7-Fr sheath.

The standard angiogram/ PCI will be performed as per usual practice. Following the PCI, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.

Conditions

Radial Artery Occlusion; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Glidesheath Slender

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

Group Type: EXPERIMENTAL

7-Fr Glidesheath Slender

Intervention Type: DEVICE

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

Standard sheath

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

Group Type: ACTIVE_COMPARATOR

Cordis 7-Fr radial sheath

Intervention Type: DEVICE

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

Interventions

7-Fr Glidesheath Slender

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

Intervention Type: DEVICE

Cordis 7-Fr radial sheath

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

Intervention Type: DEVICE

Other Intervention Names

Glidesheath Slender, Terumo, Tokyo, Japan

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kefei Dou, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital National Center for Cardiovascular Diseases

Chenggang Zhu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital National Center for Cardiovascular Diseases

Locations

Fuwai Hospital National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Hao Wang, MD,PhD

Role: CONTACT

wanghao_fuwai@126.com

+86-15701277767

Facility Contacts

Hao Wang, MD,PhD

Role: primary

wanghao_fuwai@126.com

+86-15701277767

References

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.

Reference Type: BACKGROUND

PMID: 26811162 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31753298 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27567021 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32863791 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10348538 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26839392 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39077135 (View on PubMed)

Other Identifiers

7F Glidesheath Slender

Identifier Type: -

Identifier Source: org_study_id