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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAcelet™ compression group | Experimental | the group using TRAcelet™ received 2 hours and 15 minutes of compression from the device with 13 cc of air being blown in, followed by 3 stepwise releases every 15 minutes through counterclockwise rotation of the dial without extracting air using a syringe. This achieved the same 3 hours of compression. The dial started at the triangle position and was set to nine, six, and three at every stepwise decompression. After three hours, the device was released. |
|
| Conventional compression group | Other | Patients who were assigned to the conventional group received radial artery compression by a gauze pad folded into a cuboid shape, fastened with 3M™ Durapore™ surgical tape. The gauze pad was not impregnated with prothrombotic material. Compression was released at 3 hours to check for complications. An additional one hour of compression was applied when incomplete hemostasis or hematoma was identified. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRAcelet™ | Device | 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™. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 hours after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| total hemostasis time | Total banding time | 4 hours after the procedure |
| complication of procedures | Vascular complications occurring after 2 hours of compression hemostasis at the procedure site |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsannam-do | 50612 | South Korea |
The data used to support the findings of this study are available from the corresponding author upon request.
For about an year.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| Gauze pad | Other | 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. |
|
| 2 hours after the procedure |
| complication of procedures | Radial artery occlusion | One month after the procedure |
| complication of procedures | Pain assessment : numeric pain scale(The Numeric Pain Scale is a tool used to assess a person level of pain. It typically involves asking the patient to rate their pain on a scale from 0 to 10) | 4 hours after the procedure |
| complication of procedures | 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) | 4 hours after the procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |