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Patent Hemostasis With Vasoband Versus TR Band

NCT04002791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2020-11-13

Study results available
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Summary

In patients referred for cardiac catheterization to be performed using transradial access, a randomized comparison will be performed with the primary endpoint of patency of radial artery at the time of application of hemostatic compression band. The single radial only TR-Band (Terumo, Japan) will be compared to the dual balloon Vasoband (Vasoinnovations, USA) capable of ipsilateral ulnar artery compression.

Conditions

  • Radial Artery Injury at Wrist and Hand Level

Interventions

DEVICE

VasoBand

Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression

Sponsors & Collaborators

  • Total Cardiovascular Solutions

    lead OTHER

Principal Investigators

  • Tejas M Patel, MD · Apex Heart Institute, Ahmedabad, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-16
Primary Completion
2019-10-16
Completion
2019-10-16
FDA Device
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04002791 on ClinicalTrials.gov