Clinical trial NCT06590571: The Study for Evaluate of Satety and Dfficacy of Hemostatic Device
Official title: Comparison of a Pressure-controlled Hemostatic Device With Conventional Compression for Transradial Coronary Angiography and Intervention: A Prospective, Multicenter, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Percutaneous coronary intervention
Hemostasis
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 227
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The achievement of successful hemostasis at 3 hours.
timeFrame: 3 hours after the procedure
Secondary outcomes:
measure: total hemostasis time
timeFrame: 4 hours after the procedure
measure: complication of procedures
timeFrame: 2 hours after the procedure
measure: complication of procedures
timeFrame: One month after the procedure
measure: complication of procedures
timeFrame: 4 hours after the procedure
measure: complication of procedures
timeFrame: 4 hours after the procedure
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsannam-do
Study officials:
References: