NCT04748068

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DEVICE	Cordis 7-Fr radial sheath	Avanti+ Catheter Sheath Introducer, Cordis, USA, outer diameter: 3.02 mm

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2021-02-10
• Last updated: 2021-02-10

Locations

1 site across 1 country: China