The Study for Evaluate of Satety and Dfficacy of Hemostatic Device

Not Applicable

Terminated

• Conditions: Coronary Artery Disease

• Registration Number: NCT06590571
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

The goal of this clinical trial is to compare the new pneumatic compression device TRAcelet with conventional compression method in patients undergone transradial coronary angiography. The main question it aims to answer is the achievement of successful hemostasis at 3 hours.

Researchers will compare conventional compression to see if new pneumatic device can provide better hemostasis.

Detailed Description

Although there are several devices available for radial artery hemostasis, conventional compression with a gauze pad is thought to be the easiest method. One of the devices with a pneumatic compression balloon is the TRAcelet™, and there is not much research comparing the device and conventional compression method. Therefore, the investigators aimed to compare the pneumatic compression device TRAcelet with the conventional compression method in patients who underwent transradial coronary angiography/intervention.

The primary endpoint was the achievement of successful hemostasis at 3 hours. Successful hemostasis was defined as the absence of oozing and the absence of hematoma formation after the device was released. If incomplete hemostasis was observed after 3 hours, the achievement of hemostasis after an additional hour of compression was also considered successful. Conversely, if hemostasis could not be established, it was defined as unsuccessful hemostasis. The secondary endpoints included the total banding time, local vascular complications classified according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) scale, pain or discomfort related to the transradial approach, which was assessed by the participants using the Wong-Baker Faces Pain Rating Scale and numeric pain rating scale, and the RAO at one month.

Study Timeline

• Study Start: 2018-12-14
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2024-08-16
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-07
• Last Update Submitted: 2024-09-07
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

• aged over 20 years
• Underwent coronary angiography under suspicion of coronary artery disease
• Agreed to participate in the trial before the coronary angiography procedure

Exclusion Criteria

• Bleeding tendency due to congenital or acquired disorders such as severe liver disease, thrombocytopenia (platelet count below 50,000 cells/μL)
• Those who were on anticoagulants.
• Patients who could not provide voluntary consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The achievement of successful hemostasis at 3 hours.	3 hours after the procedure	Successful hemostasis was defined as the absence of oozing and the absence of hematoma formation after the device was released. If incomplete hemostasis was observed after 3 hours, the achievement of hemostasis after an additional hour of compression was also considered successful.

Secondary Outcome Measures

Name	Time	Method
total hemostasis time	4 hours after the procedure	Total banding time
complication of procedures	4 hours after the procedure	Pain assessment :Wong-Baker Facial Grimace Scale(The Wong-Baker Facial Grimace Scale is a tool used to assess pain in patients who may have difficulty verbalizing their pain, such as children or individuals with cognitive impairments. It involves a series of facial expressions that represent varying levels of pain)

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongsannam-do, Korea, Republic of