Percutaneous Coronary Intervention
Conditions
Keywords
transradial intervention, radial artery
Brief summary
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).
Interventions
DEVICE6Fr Glidesheath Slender sheath
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.
DEVICE5Fr sheath
5Fr Hydrophilic coating sheath from Terumo.
PROCEDUREHemostasis with TR band
Hemostasis is achieved using TR band (TERUMO) Patent hemostasis.
PROCEDUREAny hemostasis procedure
Hemostasis is achieved by any hemostasis of each hospital's routine procedure.
Sponsors
European Cardiovascular Research Center
Duke Clinical Research Institute
NPO International TRI Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB. * Patient who is expected to diagnose by coronary artery angiography or followed by PCI. * Patient must agree to undergo all protocol-required follow-up examinations. * Patient who can accept radial access.
Exclusion criteria
* Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year). * Hemodialysis patient * STEMI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radial artery occlusion | Day 1 |
| Local bleeding from puncture site | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Radial spasm during the index procedure | Day 1 |
| Total Procedure Time | Day 1 |
| Total Amount of Contrast Dye | Day 1 |
| Procedure success rate | Day 1 |
| Device failure for the assigned sheath introducer | Day 1 |
| Pain score | Day 1 |
| Total Radiation Doses | Day 1 |
| Vascular access site complication | Day 1 |
Outcome results
None listed