Transradial-Band Pilot Study

NCT ID: NCT04709341

Last Updated: 2025-04-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-03

Study Completion Date

2024-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Radial Artery Incision Site Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group A

Group Type EXPERIMENTAL

TR Band 60MIN

Intervention Type DEVICE

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

Group B

Group Type ACTIVE_COMPARATOR

TR Band 120MIN

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

TR Band 120MIN

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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00088481

Identifier Type: -

Identifier Source: org_study_id

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