Clinical trial NCT06787287: A Study on the Application of Simple and Improved Radial Artery Compression Method After Transradial Coronary Intervention
Official title: A Study on the Application of Simple and Improved Radial Artery Compression Method After Transradial Coronary Intervention a Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Radial Artery Occlusion
Keywords: percutaneous coronary intervention
Compression method
Radial artery complication
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 1568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old, regardless of gender;
* Patients undergoing coronary intervention;
* Patients with a transradial approach;
* Voluntarily participate and sign informed consent;

Exclusion Criteria:

* Intraoperative Allen test was positive for all patients;
* The intraoperative Barbeau tests were all D grade radial artery patients;
* Patients with blood or liver diseases;
* Patients with vascular diseases or malformations in the forearm;
* Patients with a history of RAO at baseline of the radial artery on the approach;
* Approach side arteriovenous fistula dialysis patients;
* Patients with subclavian artery occlusive disease (definite medical history or the difference in systolic blood pressure between the two upper limbs is more than 20mmHg);
* Patients who have completed coronary intervention (full heparin);
* Active bleeding at the puncture site before extraction;
* Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg at closure;
* Pregnant women or patients who are trying to conceive and have family plans;
* Patients whom the investigator deems inappropriate to participate in the clinical trial;

Primary outcomes:
measure: Incidence of 24-hours RAO (radial artery occlusion)
timeFrame: Acute radial artery occlusion was evaluated at 24 hours after the percutaneous coronary intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Yingxian Sun
role: PRINCIPAL_INVESTIGATOR
References: