NCT06590571

The Study for Evaluate of Satety and Dfficacy of Hemostatic Device

Comparison of a Pressure-controlled Hemostatic Device With Conventional Compression for Transradial Coronary Angiography and Intervention: A Prospective, Multicenter, Randomized, Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	TRAcelet™	The group using TRAcelet™ after transradial angiography/intervention receives 2 hours and 15 minutes of compression from the device, followed by 3 stepwise releases every 15 minutes. There are two sizes of TRAcelet™ available, large and medium. Assuming that a Korean adult's wrist size is smaller than that of the Western population, we used a medium-sized TRAcelet™.
OTHER	Gauze pad	Patients received radial artery compression by a gauze pad fastened with 3M™ Durapore™ surgical tape. An additional one hour of compression was applied when incomplete hemostasis or hematoma was identified.

Timeline

• Start date: 2018-12-14
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: South Korea