Percutaneous Coronary Intervention
Conditions
Interventions
6Fr Glidesheath Slender sheath TRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS).
5Fr contemporary sheath TRI will be performed using a contemporary safety of 5Fr sheath.
Hem
s routine procedure.
Sponsors
Shonan Kamakura General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient must be at least 18 years of age. 2.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. 3.Patient who is going to have a coronary artery angiography or subsequent PCI. 4.Patient must agree to undergo all protocol-required in hospital follow-up examinations. 5.Patient who are suitable for radial access.
Exclusion criteria
Exclusion criteria: 1.Patient who has a serious medical illness 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). 2.Hemodialysis patient 3.STEMI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of freedom from radial artery occlusion (RAO) and local bleeding from the puncture site at the time of discharge or the next day, the earlier of the two. | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure success rate at the index procedure,Vascular access site complication,Radial spasm during the index procedure,Total Procedure Time ,Total Amount of Contrast Dye,Fluoroscope time,Procedure failure due to the assigned sheath,Pain score | — |
Countries
Japan,North America,Europe
Contacts
Public ContactKeiko Asou
Shonan Kamakura General Hospital Clinical research center
Outcome results
None listed