Comparing hemostatic devices for radial artery closure after heart procedures
Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI：a Randomized Controlled Trial
This study is testing a new device that uses pressure to see if it helps people stop bleeding better after heart procedures compared to the standard device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT05790603 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a patent hemostatic device with quantitative pressure compared to a conventional hemostatic device in achieving hemostasis of the radial artery following coronary angiography or percutaneous coronary intervention. Participants will be randomly assigned to either the intervention group, which uses the new device, or the control group, which uses the standard device without pressure monitoring. The study will measure outcomes such as the incidence of radial artery occlusion, time to hemostasis, and other complications over a specified period. The goal is to determine if the new device provides better hemostatic control.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing coronary angiography or percutaneous coronary intervention via the radial artery who have a positive Allen's test.
Not a fit: Patients with radial artery malformation, chronic kidney disease, liver cirrhosis, coagulation disorders, or those on specific anticoagulant therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hemostatic outcomes and reduced complications for patients undergoing coronary procedures.
How similar studies have performed: Other studies have explored hemostatic devices, but this specific approach with quantitative pressure monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Xuanwu Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
- Peking University First Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Zhenhui Tao
- Email: terry1018china@163.com
- Phone: +8613811839842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.