Transradial-Band Pilot Study

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04709341
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Radial Artery Incision Site Closure	Device: TR Band 60MIN; Device: TR Band 120MIN	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)
• Actual Study Start Date: Feb 3, 2021
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of participants with significant hematomas [an average of 12 hours post procedure]

   Hematoma >5 cm in size

2. Percentage of participants with significant hematomas [30 days post procedure]

   Hematoma >5 cm in size

3. Percentage of participants with bleeding [an average of 12 hours post procedure]

   Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma

4. Percentage of participants with bleeding [30 days post procedure]

   Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma

5. Left radial artery occlusion [an average of 12 hours post procedure]

   Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test

6. Left radial artery occlusion [30 days post procedure]

   Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ricardo Yamada, Associate Professor, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT04709341
• Other Study ID Numbers: 00088481
• First Posted: Jan 14, 2021
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Surgical Wound

Study Results

No Results Posted as of Aug 15, 2022