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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04748068
• Other study ID #: 7F Glidesheath Slender
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: February 2021
• Source: China National Center for Cardiovascular Diseases
• Contact: Hao Wang, MD,PhD
• Phone: +86-15701277767
• Email: wanghao_fuwai[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Coronary Artery Disease
• Radial Artery Occlusion

Intervention

Device:
• 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
• Cordis 7-Fr radial sheath
Avanti+ Catheter Sheath Introducer, Cordis, USA, outer diameter: 3.02 mm

Locations

Country	Name	City	State
China	Fuwai Hospital National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: J Interv Cardiol. 2020 Oct 22;2020:1303764. — View Citation

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). pii: e002686. doi: 10.1161/JAHA.115.002686. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion	Evaluated clinically and by ultrasound	24 hours
Secondary	Vascular access site complications	Includes: bleeding or hematoma, pseudoaneurysm, artery dissection, arteriovenous fistula, compartment syndrome of the forearm	24 hours
Secondary	Radial artery spasm	Radial artery spasm	24 hours
Secondary	Procedure success	completion of the planned procedure through the initially selected radial access route	24 hours
Secondary	The degree of pain at the puncture site	Scored on a scale of 1-10 scoring system	24 hours