Actively Recruiting
Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI
Led by Peking University First Hospital · Updated on 2024-07-11
200
Participants Needed
2
Research Sites
27 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
X
Xuanwu Hospital, Beijing
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing coronary angiography or percutaneous coronary intervention via the radial artery
- Positive Allen's test result
- Willing to sign informed consent
You will not qualify if you...
- Radial artery malformation
- Chronic kidney disease with eGFR less than 30 ml/min/1.73 m2
- Cirrhosis of the liver
- Coagulation dysfunction
- Patients treated with IIb/IIIa receptor antagonist
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Xuanwu Hospital
Beijing, Beijing Municipality, China, 100053
Not Yet Recruiting
2
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
Z
Zhenhui Tao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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