Transradial-Band Pilot Study

Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)

In the study group, the TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals. In the standard of care group, the TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals. The aim of the study is to reduce the time the device is in place while minimizing potential complications.

Study Overview

• Status: Completed
• Conditions: Radial Artery Incision Site Closure
• Intervention / Treatment: Device: TR Band 60MIN; Device: TR Band 120MIN

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years and older
• Have an acceptable Barbeau test (i.e. type A through C)
• Have acceptable coagulation parameters (based on PT, INR, platelet count, and appropriate pre-procedural management of anticoagulants, See Table 1)
• The caliber of the left radial artery based on a pre-procedure sonographic evaluation will need to be greater than or equal to 1.6 mm.
• The appropriate pre-procedural management of anticoagulants is based on the consensus guidelines established by Patel et al16.
• INR less than 1.5
• Platelet count greater than 50,000 platelet/uL
• Prothrombin time less than 15 seconds

Exclusion Criteria:

• If there is an unacceptable risk of bleeding diathesis, or
• If he or she is not a suitable candidate for transradial access based on a Barbeau test type D or a diameter of the left radial artery less than 1.6 mm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Device: TR Band 60MIN; TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals
Active Comparator: Group B	Device: TR Band 120MIN; TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with significant hematomas	Hematoma >5 cm in size	an average of 12 hours post procedure
Percentage of participants with significant hematomas	Hematoma >5 cm in size	30 days post procedure
Percentage of participants with bleeding	Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma	an average of 12 hours post procedure
Percentage of participants with bleeding	Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma	30 days post procedure
Left radial artery occlusion	Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test	an average of 12 hours post procedure
Left radial artery occlusion	Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test	30 days post procedure

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 00088481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No