Manual Versus Mechanical Compression of the Radial Artery After Transradial Coronary Angiography: The MEMORY Multicenter Randomized Trial.
Dimitrios Petroglou, Matthaios Didagelos, Georgios Chalikias...
https://pubmed.ncbi.nlm.nih.gov/29880098Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05790603
Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI: a Randomized Controlled Trial
Led by Peking University First Hospital · Updated on 2024-07-11
200
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating the hemostatic effect of two different devices on radial arteries after coronary angiography (CAG) or percutaneous coronary intervention (PCI). This clinical trial aims to compare a patent hemostatic device with quantitative pressure to a conventional hemostatic device without pressure monitoring. The study focuses on understanding the hemostatic effect, precise pressure, and time needed to stop bleeding after these procedures. Participants will be randomly assigned to one of two groups. The intervention group will use the PHD-Band device that applies pressure based on the patient's systolic blood pressure plus 10 mmHg, with pressure gradually released over three hours, adjusting automatically if bleeding occurs. The control group will use the TR-Band device inflated with air and gradually deflated over three hours, with adjustments if bleeding happens. Both devices are applied at the radial artery entry site after removing the sheath used in the procedure. During the study, researchers will monitor participants for complications such as bleeding, hematoma, pain, hand swelling, numbness, pseudoaneurysm, and artery narrowing. Ultrasound scans will be used within 24 hours and again at 30 days to check for artery occlusion and other issues. The main outcome measured is the rate of radial artery occlusion 24 hours after the procedure, with additional outcomes including bleeding, time to hemostasis, and other complications. Participants will be followed for at least 30 days after treatment.
CONDITIONS
Brief Title
Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI
Who Can Participate
Age: 18Years - 80Years
All Genders
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/1.73m2
- Cirrhosis of the liver
- Coagulation dysfunction
- Patients treated with IIb / IIIa receptor antagonist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 3 to 6 hours
Participants undergo percutaneous coronary intervention via the radial artery and receive either the PHD-Band with quantitative pressure or the TR-Band device for hemostasis at the puncture site. The compression devices are applied and adjusted over approximately 3 to 6 hours to stop bleeding.
1 procedure visit and monitoring during compression
Follow-up
Duration - 30 days
Participants are monitored for complications such as bleeding, hematoma, pain, swelling, numbness, pseudoaneurysm, and radial artery occlusion. Radial artery status is assessed by arterial ultrasound within 24 hours and again at 30 days after the procedure.
2 visits (within 24 hours and at 30 days post-procedure)
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
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Research Team
Z
Zhenhui Tao
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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https://pubmed.ncbi.nlm.nih.gov/3233513The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial.
Péter Kulyassa, Balázs T Németh, Réka Ehrenberger...
https://pubmed.ncbi.nlm.nih.gov/35694680Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography.
Guering Eid-Lidt, Jesús Reyes-Carrera, Julio I Farjat-Pasos...
https://pubmed.ncbi.nlm.nih.gov/35589232