NCT05790603 Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI
| NCT ID | NCT05790603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Percutaneous Coronary Intervention |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-05-21 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: Patients undergoing coronary angiography or percutaneous coronary intervention via the radial artery; Positive Allen's test result; Willing to sign informed consent. Exclusion Criteria: 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.
Contact & Investigator
Zhenhui Tao
STUDY CHAIR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT05790603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Percutaneous Coronary Intervention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05790603 currently recruiting?
Yes, NCT05790603 is actively recruiting participants. Contact the research team at terry1018china@163.com for enrollment information.
Where is the NCT05790603 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT05790603 clinical trial?
NCT05790603 is sponsored by Peking University First Hospital. The principal investigator is Zhenhui Tao at Peking University First Hospital. The trial plans to enroll 200 participants.