Coronary Artery DiseaseNCT06787287
A Study on the Application of Simple and Improved Radial Artery Compression Method After Transradial Coronary Intervention
A study testing Modified compression method in people with Coronary Artery Disease and Radial Artery Occlusion, run by Guozhe Sun at 1 site in China.
Trial summary
The objective of this study was to evaluate the specific effect of a simple modified method of thick gauze (9cm*16cm*8mm) combined with a hemostatic device in the prevention of early radial artery occlusion and other related vascular complications after transradial coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Radial Artery Occlusion
- What is being tested?
- Modified compression method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,624 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2023to 10 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old, regardless of gender;
- Patients undergoing coronary intervention;
- Patients with a transradial approach;
- Voluntarily participate and sign informed consent;
Who cannot join
- Intraoperative Allen test was positive for all patients;
- The intraoperative Barbeau tests were all D grade radial artery patients;
- Patients with blood or liver diseases;
- Patients with vascular diseases or malformations in the forearm;
- Patients with a history of RAO at baseline of the radial artery on the approach;
- Approach side arteriovenous fistula dialysis patients;
Show all 12Show fewer
- Patients with subclavian artery occlusive disease (definite medical history or the difference in systolic blood pressure between the two upper limbs is more than 20mmHg);
- Patients who have completed coronary intervention (full heparin);
- Active bleeding at the puncture site before extraction;
- Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg at closure;
- Pregnant women or patients who are trying to conceive and have family plans;
- Patients whom the investigator deems inappropriate to participate in the clinical trial;
Trial locations and contacts
1 site in 1 country.
China1 site
First Hospital of China Medical University
Shenyang, Liaoning, China
About this study
Official title: A Study on the Application of Simple and Improved Radial Artery Compression Method After Transradial Coronary Intervention A Randomized, Controlled Clinical Trial
The objective of this study was to evaluate the specific effect of a simple modified method of thick gauze (9cm*16cm*8mm) combined with a hemostatic device in the prevention of early radial artery occlusion and other related vascular complications after transradial coronary intervention.
Read the detailed description
Clinically, coronary intervention through radial artery is a common path for cardiovascular interventional therapy in recent years, and relevant clinical RCT studies and meta-analyses have confirmed that transradial intervention (TRI) has more benefits than transfemoral artery. Including reducing patient pain, easy pressure hemostasis, postoperative patients can not have to stay in bed, fewer vascular complications, reduce patient hospitalization costs and other advantages. However, radial artery occlusion (RAO) and hematoma are the most common postoperative complications of TRA. Although the vast majority of cases are asymptomatic from an ischemia perspective, it rules out ipsilateral TRA for future surgery. In particular, RAO will restrict the use of the radial artery to create an arteriovenous fistula for patients requiring hemodialysis, in addition to the fact that patients at high blood risk may not receive the benefits of the radial artery access in the case of repeat surgery. Therefore, the prevention of postoperative RAO is of fundamental clinical importance. Among the various strategies used to prevent RAO, postoperative arterial compression time and arterial compression level are important factors in changing the occurrence of RAO. In the CRASOC study, which included 3616 patients who were randomly divided into 3 groups, the incidence of RAO was 2.3% when hemostatic compression (10 ml of air) was light and short (1.5 hours). The incidence of RAO was 7.9% when hemostatic compression was lighter (10 ml of air) but longer (4 hours) and 9.4% when stronger pressure was applied (13 ml of air) and longer (4 hours), and the CRASOC trial highlights the effectiveness of combining a minimum pressure strategy with a short compression duration for the prevention of RAO. However, a very short compression duration may increase the rate of rebleeding at the puncture site, resulting in a renewed need for increased hemostatic pressure, which may paradoxically increase the incidence of RAO.
At present, when traditional pressure hemostasis is difficult in clinic or postoperative pressure pain is unbearable, our center often adopts a simple and improved method of thick gauze block (9cm*16cm*8mm) combined with hemostatic device, which can significantly improve the hemostatic effect. However, this method is only in the experience of single-center surgeons and has not been verified by relevant clinical studies. The center intends to conduct this clinical study to systematically evaluate the application effect of this improved compression method in radial artery compression hemostasis after transradial coronary intervention.
- Conditions
- Coronary Artery Disease, Radial Artery Occlusion
- Being tested
- Modified compression method
- Keywords
- percutaneous coronary intervention, Compression method, Radial artery complication
- Medical subject headings
- Coronary Artery Disease, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified compression methodProcedure or surgery
In the experimental group, an improved compression method was adopted. A thick gauze block of 9cm*16cm*8mm was folded three times and placed at the puncture site of the patient's radial artery, and a spiral radial artery hemostatic device was placed above it. The control group was treated with traditional compression method, and the spiral radial artery hemostat was applied directly at the radial artery puncture
| Study group | Role | What they receive |
|---|---|---|
| The experimental group adopted improved compression method | Experimental | The experimental group adopted the improved compression method. A thick gauze block of 9cm*16cm*8mm was folded three times and placed at the puncture site of the patient's radial artery, and a spiral radial artery hemostatic device was placed above it. After rotating the hemostatic device several times clockwise to confirm that there was no bleeding at the puncture site, and then rotating the hemostatic device counterclockwise to make the radial artery hemorrhage occurred. The hemostatic device was turned clockwise again to stop the bleeding of the radial artery, and then turned counterclockwise every 1 hour. After continuous pressure on the puncture site for 4 hours, the band was removed and sterilized and covered with sterile dressing. Patients were monitored for at least 30 minutes after the band was removed. If the bleeding reappears, re-apply the band and repeat the process.
24 hours after surgery, color Doppler ultrasound was used to determine the presence or absence of a radial Receives: Procedure: Modified compression method |
| The control group was treated with traditional compression method | No intervention | The control group was treated with the traditional compression method. The spiral radial artery hemostatic device was applied at the radial artery puncture, and the radial artery was completely hemostatic after several turns clockwise, and then the radial artery was completely hemostatic after counterclockwise rotation, and then the radial artery was stopped bleeding after one turn clockwise rotation, that is, the minimal pressure was applied to ensure successful hemostasis. Then the hemostat was turned counterclockwise every 1 hour, and the puncture site was pressed continuously for 4 hours. The band was removed and covered with sterile dressing after disinfection. Patients were monitored for at least 30 minutes after the band was removed. If the bleeding reappears, re-apply the band and repeat the process. 24 hours after surgery, color Doppler ultrasound was used to determine the presence or absence of a radial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 24-hours RAO (radial artery occlusion)
Color Doppler ultrasound was used to determine the incidence of RAO (radial artery occlusion) at 24 hours after the percutaneous coronary intervention in both groups
Measured: Acute radial artery occlusion was evaluated at 24 hours after the percutaneous coronary intervention
Secondary outcomes (7)
Occurrence of forearm hematomas
Forearm hematomas were recorded and graded using the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) classification system, based on size and clinical presentation.
Grade I: Localized, superficial hematoma. Grade II: Hematoma with moderate muscle infiltration. Grade III: Forearm hematoma with muscle infiltration extending to below the elbow.
Grade IV: Hematoma and muscle infiltration extending above the elbow. Grade V: Ischemic threat (compartment syndrome), representing the most severe condition.
Measured: Within 24 hours after the procedure
Postoperative pain within 24 hours
Pain intensity at the puncture site was assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 24 hours after the procedure
Presence of palm swelling
Palm swelling was defined as a circumference increase of more than 0.5 cm compared with baseline, measured at the same palm location using a flexible tape measure.
Measured: Within 24 hours after the procedure
Occurrence of forearm cyanosis
Cyanosis was visually assessed and defined as discoloration (bluish or purple tint) of the forearm skin, indicating impaired circulation.
Measured: Within 24 hours after the procedure
Presence of finger numbness
Numbness was assessed by patient report and physical examination, defined as subjective loss or reduction of sensation in one or more fingers on the puncture side.
Measured: Within 24 hours after the procedure
Incidence of tension blisters at the puncture site
Tension blisters were visually assessed and categorized as mild (small, localized, minimal pain) or severe (large, spreading, or with associated significant pain), based on extent and patient-reported symptoms.
Measured: Within 24 hours after the procedure
Change in radial artery diameter from baseline
Radial artery internal diameter was measured using color Doppler ultrasound at baseline and at 24 hours after the procedure, and the change was calculated to assess vascular response.
Measured: From baseline to 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start31 Jul 2023
- Primary completion30 Apr 2025
- Study completion10 May 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guozhe Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guozhe Sun, China Medical University, China
- Investigators
- Yingxian Sun, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787287
- Sponsor's protocol ID
- 【2023】2023-341-2
- Status last verified
- Sep 2025
- First submitted
- 10 Jan 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Application of Simple and Improved Radial Artery Compression Method After Transradial Coronary Intervention A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06787287
- Acronym / sponsor ID
- 【2023】2023-341-2
- Conditions
- Coronary Artery Disease, Radial Artery Occlusion
- Keywords
- percutaneous coronary intervention, Compression method, Radial artery complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,624 participants (actual)
- Lead sponsor
- Guozhe SunUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 22 Jan 2025 (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 objective of this study was to evaluate the specific effect of a simple modified method of thick gauze (9cm*16cm*8mm) combined with a hemostatic device in the prevention of early radial artery occlusion and other related vascular complications after transradial coronary intervention.
Detailed description
Clinically, coronary intervention through radial artery is a common path for cardiovascular interventional therapy in recent years, and relevant clinical RCT studies and meta-analyses have confirmed that transradial intervention (TRI) has more benefits than transfemoral artery. Including reducing patient pain, easy pressure hemostasis, postoperative patients can not have to stay in bed, fewer vascular complications, reduce patient hospitalization costs and other advantages. However, radial artery occlusion (RAO) and hematoma are the most common postoperative complications of TRA. Although the vast majority of cases are asymptomatic from an ischemia perspective, it rules out ipsilateral TRA for future surgery. In particular, RAO will restrict the use of the radial artery to create an arteriovenous fistula for patients requiring hemodialysis, in addition to the fact that patients at high blood risk may not receive the benefits of the radial artery access in the case of repeat surgery. Therefore, the prevention of postoperative RAO is of fundamental clinical importance. Among the various strategies used to prevent RAO, postoperative arterial compression time and arterial compression level are important factors in changing the occurrence of RAO. In the CRASOC study, which included 3616 patients who were randomly divided into 3 groups, the incidence of RAO was 2.3% when hemostatic compression (10 ml of air) was light and short (1.5 hours). The incidence of RAO was 7.9% when hemostatic compression was lighter (10 ml of air) but longer (4 hours) and 9.4% when stronger pressure was applied (13 ml of air) and longer (4 hours), and the CRASOC trial highlights the effectiveness of combining a minimum pressure strategy with a short compression duration for the prevention of RAO. However, a very short compression duration may increase the rate of rebleeding at the puncture site, resulting in a renewed need for increased hemostatic pressure, which may paradoxically increase the incidence of RAO.
At present, when traditional pressure hemostasis is difficult in clinic or postoperative pressure pain is unbearable, our center often adopts a simple and improved method of thick gauze block (9cm*16cm*8mm) combined with hemostatic device, which can significantly improve the hemostatic effect. However, this method is only in the experience of single-center surgeons and has not been verified by relevant clinical studies. The center intends to conduct this clinical study to systematically evaluate the application effect of this improved compression method in radial artery compression hemostasis after transradial coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group adopted improved compression method | Experimental | Procedure: Modified compression methodThe experimental group adopted the improved compression method. A thick gauze block of 9cm*16cm*8mm was folded three times and placed at the puncture site of the patient's radial artery, and a spiral radial artery hemostatic device was placed above it. After rotating the hemostatic device several times clockwise to confirm that there was no bleeding at the puncture site, and then rotating the hemostatic device counterclockwise to make the radial artery hemorrhage occurred. The hemostatic device was turned clockwise again to stop the bleeding of the radial artery, and then turned counterclockwise every 1 hour. After continuous pressure on the puncture site for 4 hours, the band was removed and sterilized and covered with sterile dressing. Patients were monitored for at least 30 minutes after the band was removed. If the bleeding reappears, re-apply the band and repeat the process. 24 hours after surgery, color Doppler ultrasound was used to determine the presence or absence of a radial |
| The control group was treated with traditional compression method | No intervention | –The control group was treated with the traditional compression method. The spiral radial artery hemostatic device was applied at the radial artery puncture, and the radial artery was completely hemostatic after several turns clockwise, and then the radial artery was completely hemostatic after counterclockwise rotation, and then the radial artery was stopped bleeding after one turn clockwise rotation, that is, the minimal pressure was applied to ensure successful hemostasis. Then the hemostat was turned counterclockwise every 1 hour, and the puncture site was pressed continuously for 4 hours. The band was removed and covered with sterile dressing after disinfection. Patients were monitored for at least 30 minutes after the band was removed. If the bleeding reappears, re-apply the band and repeat the process. 24 hours after surgery, color Doppler ultrasound was used to determine the presence or absence of a radial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old, regardless of gender;
- Patients undergoing coronary intervention;
- Patients with a transradial approach;
- Voluntarily participate and sign informed consent;
Key exclusion criteria (12 listed)
- Intraoperative Allen test was positive for all patients;
- The intraoperative Barbeau tests were all D grade radial artery patients;
- Patients with blood or liver diseases;
- Patients with vascular diseases or malformations in the forearm;
- Patients with a history of RAO at baseline of the radial artery on the approach;
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 |
|---|---|---|
| Modified compression methodIn the experimental group, an improved compression method was adopted. A thick gauze block of 9cm*16cm*8mm was folded three times and placed at the puncture site of the patient's radial artery, and a spiral radial artery hemostatic device was placed above it. The control group was treated with traditional compression method, and the spiral radial artery hemostat was applied directly at the radial artery puncture | Procedure or surgery | The experimental group adopted improved compression method |
Primary outcome
Incidence of 24-hours RAO (radial artery occlusion)
Time frame: Acute radial artery occlusion was evaluated at 24 hours after the percutaneous coronary intervention
Color Doppler ultrasound was used to determine the incidence of RAO (radial artery occlusion) at 24 hours after the percutaneous coronary intervention in both groups
7 secondary outcomes
Occurrence of forearm hematomas
Time frame: Within 24 hours after the procedure
Postoperative pain within 24 hours
Time frame: 24 hours after the procedure
Presence of palm swelling
Time frame: Within 24 hours after the procedure
Occurrence of forearm cyanosis
Time frame: Within 24 hours after the procedure
Presence of finger numbness
Time frame: Within 24 hours after the procedure
Incidence of tension blisters at the puncture site
Time frame: Within 24 hours after the procedure
Change in radial artery diameter from baseline
Time frame: From baseline to 24 hours post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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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.
Yingxian Sun principal investigator
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified compression method in people with Coronary Artery Disease and Radial Artery Occlusion, run by Guozhe Sun at 1 site in China.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 22 Oct 2026. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of 24-hours RAO (radial artery occlusion) (time frame: Acute radial artery occlusion was evaluated at 24 hours after the percutaneous coronary intervention). 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 22 Oct 2026.