Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI
- Conditions
- Percutaneous Coronary InterventionHemostasis
- Interventions
- Device: Control group with TR-BandDevice: Intervention group with PHD-Band
- Registration Number
- NCT05790603
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
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 coronary angiography (CAG) or percutaneous coronary intervention (PCI). The main questions aims to answer:
* What is the hemostatic effect of the patent hemostatic device with quantitative pressure after percutaneous coronary intervention?
* What are the precise hemostatic pressure and hemostatic time of the radial artery after CAG/PCI? Participants will be randomly assigned to the intervention group (IG) and control group (CG). The IG will use patent hemostatic device with quantitative pressure (PHDQP-Band, China) while the CG will use the conventional radial artery hemostatic device (TR-Band, Japan) without pressure monitoring.
The primary outcomes is incidence of 24h radial artery occlusion (24h RAO). Secondary outcomes include time to hemostasis, bleeding, hematoma, 30d radial artery occlusion (30d RAO), pain, hand swelling, numberness, pseudoaneurysm, and radial artery stenosis.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Patients undergoing coronary angiography or percutaneous coronary intervention via the radial artery; Positive Allen's test result; Willing to sign informed consent.
Radial artery malformation； Chronic kidney disease with eGFR<30ml/min.1.73m2; Cirrhosis of the liver; Coagulation disfunction; Patients treated with IIb / IIIa receptor antagonist.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control group with TR-Band TR-band Group Intervention group Intervention group with PHD-Band PHD-band Group
- Primary Outcome Measures
Name Time Method Incidence early radial artery occlusion Within 24 hours after CAG/PCI RAO occurs within 24 hours after CAG/PCI
- Secondary Outcome Measures
Name Time Method The degree of pain baseline; 24 hours after PCI Pain level is classified as painless: 0; mild pain: 1\~3; moderate pain: 4\~6; severe pain: 7\~10.
Incidence of access site bleeding Within 24 hours after CAG/PCI Access site bleeding within 24 hours after CAG/PCI
Compression time through hemostasis completion，estimated to be an average of 3~6hours The interval from the time of sheath removal to the time of hemostasis removal
Incidence of hematoma through hemostasis completion，estimated to be an average of 4~6hours The incidence of subcutaneous hematoma in the distal skin of the compression site 24 h after the removal of the compression device
Incidence of 30d radial artery occlusion Within 30 days after CAG/PCI RAO occurs within 30 days after CAG/PCI
Hand swelling baseline; 24 hours after PCI The circumference diameter of both hands was measured using a tape gauge contrast.
pseudoaneurysm Within 24 hours after PCI It refers to the lumen of the same as the artery formed by the blood through the perivascular tissue after arterial puncture.
numbness baseline; 24 hours after PCI Numbness level is classified as no numbness with 0, mild numbness: 1\~2; moderate numbness: 3; severe numbness:4\~5
Trial Locations
- Locations (2)
Xuanwu Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, China