The objective of this clinical trial is to compare the hemostatic effect of 2 hemostatic
devices with or without quantitative pressure on radial arteries after percutaneous
coronary intervention. The main questions aims to answer:
What is the hemostatic effect of the patent hemostatic device after percutaneous
coronary intervention?
What are the precise hemostasis pressure and hemostasis time of the radial artery
after percutaneous coronary intervention?
Participants will be randomly assigned to the intervention group (IG) and control group
(CG).
For the participants assigned to the IG, the radial systolic pressure will be measured
after TRA procedure. The PHD-Band with quantitative pressure ( WEGO Medical Products
Group CO. LTD, China) will be placed at the entry site of the sheath. Connecting the
hemostatic devices to the electric pneumatic machine with a connecting cable. After
removing the radial sheath, the puncture site will be compressed by operator's hand. The
PHD-Band with quantitative pressure will be inflated with specific pressure radial
systolic pressure plus 10mmHg) and the hand will slowly release the pressure. If bleeding
occurs, the PHD-Band will be deflated with 5-10mmHg automatically by parameter setting
with the electric pneumatic machine until the bleeding stops. The PHD-Band will be
deflated with20 mmHg, 40 mmHg of decreased pressure following 1h and 2h after the
procedure. After 3 hours, the hemostatic pressure will be released to 45mmHg and the
PHD-Band will be removed if no bleeding occurs. If rebleeding occurs, the band will be
inflated according to the previous pressure for another an hour until bleeding stops.
For the participants assigned to the CG, the TR-Band (Terumo Medical Corporation, Japan)
will be placed at the entry site of the sheath after TRA procedure and inflated with 10
mL of air and the radial sheath will be removed with hand compression. Another 5 mL of
air will be inflated and the operator's hand will slowly release the pressure. The TR
band will be inflated until bleeding stopped with the maximum air volume no more than
18ml. The band will be deflated with 1 mL of air hourly for the following 2 hours after
the procedure. After 3 hours, the band will be deflated with 4 mL of air first and then
all volume of the rest air if no bleeding occurs and then the band will be removed if no
bleeding occurs. If rebleeding occurs, the band will be inflated with 1 mL of air until
bleeding stops .
For all enrolled participants, the investigators will record the complications such as
bleeding, subcutaneous hematoma, pain, hand swelling, numbness, pseudoaneurysm after the
operation. Radial artery occlusion, subcutaneous hematoma, pseudoaneurysm, and radial
artery stenosis were confirmed by arterial ultrasound within 24 hours and 30 days after
surgery.