Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590571
Status:
TERMINATED
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
The Study for Evaluate of Satety and Dfficacy of Hemostatic Device
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of a Pressure-controlled Hemostatic Device With Conventional Compression for Transradial Coronary Angiography and Intervention A Prospective Multicenter Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The company stopped manufacturing the product
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 angiographyintervention
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None