The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
1,900
6Fr sheath (Glidesheath slender: GSS), which is characterized with the same inner lumen diameter with contemporary 6Fr sheath as well as the sheath outer diameter similar with contemporary 5Fr sheath.
5Fr Hydrophilic coating sheath from Terumo.
Hemostasis is achieved using TR band (TERUMO) Patent hemostasis.
Radial artery occlusion
Time frame: Day 1
Local bleeding from puncture site
Time frame: Day 1
Procedure success rate
Time frame: Day 1
Vascular access site complication
Time frame: Day 1
Radial spasm during the index procedure
Time frame: Day 1
Total Procedure Time
Time frame: Day 1
Total Amount of Contrast Dye
Time frame: Day 1
Total Radiation Doses
Time frame: Day 1
Device failure for the assigned sheath introducer
Time frame: Day 1
Pain score
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hemostasis is achieved by any hemostasis of each hospital's routine procedure.