The Study for Evaluate of Satety and Dfficacy of Hemostatic Device

NCT06590571 | Terminated

• 1 other identifier: TRAcelet study
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Percutaneous coronary intervention; Hemostasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• total hemostasis time

  4 hours after the procedure

• complication of procedures

  2 hours after the procedure

• complication of procedures

  One month after the procedure

• complication of procedures

  4 hours after the procedure

• complication of procedures

  4 hours after the procedure

Study Arms (2)

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.

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.

Other: Gauze pad

Interventions

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™.

TRAcelet™ compression group

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.

Conventional compression group

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged over 20 years
• Underwent coronary angiography under suspicion of coronary artery disease
• Agreed to participate in the trial before the coronary angiography procedure

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsannam-do, 50612, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: September 19, 2024
• Study Start: December 14, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For about an year.

Locations

KR (1)