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

National Center for Cardiovascular Diseases

Status: Unknown

Conditions: Coronary Artery Disease; Radial Artery Occlusion

Treatments: Device: Cordis 7-Fr radial sheath; Device: 7-Fr Glidesheath Slender

Study type: Interventional

Funder types: Other

Identifiers

NCT04748068

7F Glidesheath Slender

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Glidesheath Slender

Experimental group

Description:

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

Treatment:

Device: 7-Fr Glidesheath Slender

Standard sheath

Active Comparator group

Description:

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

Treatment:

Device: Cordis 7-Fr radial sheath