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

NCT06787287 | Completed

• 1 other identifier: 【2023】2023-341-2
• Study Type: interventional
• Target: 1,568
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Radial Artery Occlusion

Keywords

percutaneous coronary intervention; Compression method; Radial artery complication

Outcome Measures

Primary Outcomes (1)

• Incidence of 24-hours RAO (radial artery occlusion)

  Color Doppler ultrasound was used to determine the incidence of RAO (radial artery occlusion) at 24 hours after the percutaneous coronary intervention in both groups

  Acute radial artery occlusion was evaluated at 24 hours after the percutaneous coronary intervention

Secondary Outcomes (7)

• Occurrence of forearm hematomas

  Within 24 hours after the procedure

• Postoperative pain within 24 hours

  24 hours after the procedure

• Presence of palm swelling

  Within 24 hours after the procedure

• Occurrence of forearm cyanosis

  Within 24 hours after the procedure

• Presence of finger numbness

  Within 24 hours after the procedure

Study Arms (2)

The experimental group adopted improved compression method

EXPERIMENTAL

The experimental group adopted the improved compression method. 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. After rotating the hemostatic device several times clockwise to confirm that there was no bleeding at the puncture site, and then rotating the hemostatic device counterclockwise to make the radial artery hemorrhage occurred. The hemostatic device was turned clockwise again to stop the bleeding of the radial artery, and then turned counterclockwise every 1 hour. After continuous pressure on the puncture site for 4 hours, the band was removed and sterilized and covered with sterile dressing. Patients were monitored for at least 30 minutes after the band was removed. If the bleeding reappears, re-apply the band and repeat the process. 24 hours after surgery, color Doppler ultrasound was used to determine the presence or absence of a radial

Procedure: Modified compression method

The control group was treated with traditional compression method

NO INTERVENTION

The control group was treated with the traditional compression method. The spiral radial artery hemostatic device was applied at the radial artery puncture, and the radial artery was completely hemostatic after several turns clockwise, and then the radial artery was completely hemostatic after counterclockwise rotation, and then the radial artery was stopped bleeding after one turn clockwise rotation, that is, the minimal pressure was applied to ensure successful hemostasis. Then the hemostat was turned counterclockwise every 1 hour, and the puncture site was pressed continuously for 4 hours. The band was removed and covered with sterile dressing after disinfection. Patients were monitored for at least 30 minutes after the band was removed. If the bleeding reappears, re-apply the band and repeat the process. 24 hours after surgery, color Doppler ultrasound was used to determine the presence or absence of a radial

Interventions

Modified compression method PROCEDURE

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

The experimental group adopted improved compression method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guozhe Sun: lead

Study Sites (1)

First Hospital of China Medical University

Shenyang, Liaoning, China, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Vascular Diseases

Study Officials

• Yingxian Sun

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: sub-investigator of Department of Cardiology in First Hospital of China Medical University

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 22, 2025
• Study Start: July 31, 2023
• Primary Completion: April 30, 2025
• Study Completion: May 10, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CN (1)