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Transradial-Band Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04709341
Recruitment Status : Enrolling by invitation
First Posted : January 14, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Ricardo Yamada, Medical University of South Carolina

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 3, 2021
Estimated Primary Completion Date : February 3, 2022
Estimated Study Completion Date : February 3, 2022
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Percentage of participants with significant hematomas [ Time Frame: an average of 12 hours post procedure ]
    Hematoma >5 cm in size

  2. Percentage of participants with significant hematomas [ Time Frame: 30 days post procedure ]
    Hematoma >5 cm in size

  3. Percentage of participants with bleeding [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 days post procedure ]
    Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709341


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
More Information
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Responsible Party: Ricardo Yamada, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04709341    
Other Study ID Numbers: 00088481
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Surgical Wound
Wounds and Injuries