NCT06787287

A Study on the Application of Simple and Improved Radial Artery Compression Method After Transradial Coronary Intervention

A Study on the Application of Simple and Improved Radial Artery Compression Method After Transradial Coronary Intervention A Randomized, Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,568 (actual)
• Sponsor: Guozhe Sun · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to evaluate the specific effect of a simple modified method of thick gauze (9cm\*16cm\*8mm) combined with a hemostatic device in the prevention of early radial artery occlusion and other related vascular complications after transradial coronary intervention.

Detailed description

Clinically, coronary intervention through radial artery is a common path for cardiovascular interventional therapy in recent years, and relevant clinical RCT studies and meta-analyses have confirmed that transradial intervention (TRI) has more benefits than transfemoral artery. Including reducing patient pain, easy pressure hemostasis, postoperative patients can not have to stay in bed, fewer vascular complications, reduce patient hospitalization costs and other advantages. However, radial artery occlusion (RAO) and hematoma are the most common postoperative complications of TRA. Although the vast majority of cases are asymptomatic from an ischemia perspective, it rules out ipsilateral TRA for future surgery. In particular, RAO will restrict the use of the radial artery to create an arteriovenous fistula for patients requiring hemodialysis, in addition to the fact that patients at high blood risk may not receive the benefits of the radial artery access in the case of repeat surgery. Therefore, the prevention of postoperative RAO is of fundamental clinical importance. Among the various strategies used to prevent RAO, postoperative arterial compression time and arterial compression level are important factors in changing the occurrence of RAO. In the CRASOC study, which included 3616 patients who were randomly divided into 3 groups, the incidence of RAO was 2.3% when hemostatic compression (10 ml of air) was light and short (1.5 hours). The incidence of RAO was 7.9% when hemostatic compression was lighter (10 ml of air) but longer (4 hours) and 9.4% when stronger pressure was applied (13 ml of air) and longer (4 hours), and the CRASOC trial highlights the effectiveness of combining a minimum pressure strategy with a short compression duration for the prevention of RAO. However, a very short compression duration may increase the rate of rebleeding at the puncture site, resulting in a renewed need for increased hemostatic pressure, which may paradoxically increase the incidence of RAO. At present, when traditional pressure hemostasis is difficult in clinic or postoperative pressure pain is unbearable, our center often adopts a simple and improved method of thick gauze block (9cm\*16cm\*8mm) combined with hemostatic device, which can significantly improve the hemostatic effect. However, this method is only in the experience of single-center surgeons and has not been verified by relevant clinical studies. The center intends to conduct this clinical study to systematically evaluate the application effect of this improved compression method in radial artery compression hemostasis after transradial coronary intervention.

Conditions

• Coronary Artery Disease
• Radial Artery Occlusion

Interventions

Type	Name	Description
PROCEDURE	Modified compression method	In the experimental group, an improved compression method was adopted. A thick gauze block of 9cm\*16cm\*8mm was folded three times and placed at the puncture site of the patient's radial artery, and a spiral radial artery hemostatic device was placed above it. The control group was treated with traditional compression method, and the spiral radial artery hemostat was applied directly at the radial artery puncture

Timeline

• Start date: 2023-07-31
• Primary completion: 2025-04-30
• Completion: 2025-05-10
• First posted: 2025-01-22
• Last updated: 2025-10-02

Locations

1 site across 1 country: China