Transradial-Band Pilot Study

Medical University of South Carolina30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Radial Artery Incision Site Closure

Interventions

TR Band 60MINDEVICE

TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals

TR Band 120MINDEVICE

TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Percentage of Participants With Bleeding

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

Time frame: 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

Time frame: 30 days post procedure

Left Radial Artery Occlusion

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

Time frame: 30 days post procedure

Data from ClinicalTrials.gov

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