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

Not Applicable

• Conditions: Radial Artery Occlusion; Coronary Artery Disease
• Interventions: Device: Cordis 7-Fr radial sheath; Device: 7-Fr Glidesheath Slender

• Registration Number: NCT04748068
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Study Timeline

• Study First Submitted: 2021-01-25
• Status Verified: 2021-02
• Study Start: 2021-02-01
• Study First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Study First Posted: 2021-02-10
• Last Update Posted: 2021-02-10
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard sheath	Cordis 7-Fr radial sheath	The transradial procedure will be performed using the standard 7- French radial sheath (comparator sheath)
Glidesheath Slender	7-Fr Glidesheath Slender	The transradial procedure will be performed using the 7-Fr glidesheath slender (studied sheath)

Primary Outcome Measures

Name	Time	Method
Radial artery occlusion	24 hours	Evaluated clinically and by ultrasound

Secondary Outcome Measures

Name	Time	Method
The degree of pain at the puncture site	24 hours	Scored on a scale of 1-10 scoring system
Vascular access site complications	24 hours	Includes: bleeding or hematoma, pseudoaneurysm, artery dissection, arteriovenous fistula, compartment syndrome of the forearm
Radial artery spasm	24 hours	Radial artery spasm
Procedure success	24 hours	completion of the planned procedure through the initially selected radial access route

Trial Locations

Locations (1)

Fuwai Hospital National Center for Cardiovascular Diseases; 🇨🇳 Beijing, Beijing, China