Coronary Artery Disease Clinical Trial
Official title:
Use of Glidesheath Slender to Reduce Radial Artery Occlusion Following 7 French Transradial Coronary Intervention
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.
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. ;
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