Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT04748068
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:
NCT04748068
Study Brief:
Protocol Section:
NCT04748068