Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, Percutaneous coronary intervention, Hemostasis
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.
Interventions
OTHERGauze 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.
DEVICETRAcelet™
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™.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Simple randomization was performed at the end of each coronary angiography procedure using a randomization table provided by the website (http://stattrek.com/Tables/Random.aspx). Investigators were able to identify the assignment only after the coronary angiography procedure and before the removal of the sheath catheter.
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| total hemostasis time | 4 hours after the procedure | Total banding time |
| complication of procedures | 2 hours after the procedure | Vascular complications occurring after 2 hours of compression hemostasis at the procedure site |
Countries
South Korea
Outcome results
None listed