Coronary Artery DiseaseNCT06590571
The Study for Evaluate of Satety and Dfficacy of Hemostatic Device
A study testing TRAcelet™ and Gauze pad in people with Coronary Artery Disease, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- TRAcelet™ and Gauze pad
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Dec 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged over 20 years
- Underwent coronary angiography under suspicion of coronary artery disease
- Agreed to participate in the trial before the coronary angiography procedure
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsannam-do, 50612
About this study
Official title: Comparison of a Pressure-controlled Hemostatic Device With Conventional Compression for Transradial Coronary Angiography and Intervention: A Prospective, Multicenter, Randomized, Controlled Trial
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.
Read the 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
- Being tested
- TRAcelet™, Gauze pad
- Keywords
- Coronary artery disease, Percutaneous coronary intervention, Hemostasis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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™.
Gauze padOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TRAcelet™ |
| 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. Receives: Other: Gauze pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours after the procedure
Secondary outcomes (5)
total hemostasis time
Total banding time
Measured: 4 hours after the procedure
complication of procedures
Vascular complications occurring after 2 hours of compression hemostasis at the procedure site
Measured: 2 hours after the procedure
complication of procedures
Radial artery occlusion
Measured: 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)
Measured: 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)
Measured: 4 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Dec 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: The company stopped manufacturing the product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Ku Chon, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590571
- Sponsor's protocol ID
- TRAcelet study
- Status last verified
- Sep 2024
- First submitted
- 16 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data used to support the findings of this study are available from the corresponding author upon request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Pressure-controlled Hemostatic Device With Conventional Compression for Transradial Coronary Angiography and Intervention: A Prospective, Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06590571
- Acronym / sponsor ID
- TRAcelet study
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Percutaneous coronary intervention, Hemostasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The company stopped manufacturing the product
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TRAcelet™ compression group | Experimental | Device: TRAcelet™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 | Other: Gauze padPatients 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. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged over 20 years
- Underwent coronary angiography under suspicion of coronary artery disease
- Agreed to participate in the trial before the coronary angiography procedure
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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™. | Device | TRAcelet™ compression group |
| Gauze padPatients 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. | Other | Conventional compression group |
Primary outcome
The achievement of successful hemostasis at 3 hours.
Time frame: 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.
5 secondary outcomes
total hemostasis time
Time frame: 4 hours after the procedure
complication of procedures
Time frame: 2 hours after the procedure
complication of procedures
Time frame: One month after the procedure
complication of procedures
Time frame: 4 hours after the procedure
complication of procedures
Time frame: 4 hours after the procedure
Results and safety
The study was stopped early (reason given: The company stopped manufacturing the product). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. The data used to support the findings of this study are available from the corresponding author upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAcelet™ and Gauze pad in people with Coronary Artery Disease, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The company stopped manufacturing the product). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The achievement of successful hemostasis at 3 hours. (time frame: 3 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.