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Patent Hemostasis With Vasoband Versus TR Band (OPEN-Radial)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04002791
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Information provided by (Responsible Party):
Total Cardiovascular Solutions

Brief 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.

Condition or disease Intervention/treatment Phase
Radial Artery Injury at Wrist and Hand Level Device: VasoBand Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized comparison of patent hemostasis achievement with single bladder radial artery compression device with a dual-bladder ulnar compression capable radial artery compression device.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized COmparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Patent Hemostasis: OPEN-Radial Trial
Actual Study Start Date : March 16, 2019
Estimated Primary Completion Date : September 16, 2019
Estimated Study Completion Date : September 16, 2019

Arm Intervention/treatment
Placebo Comparator: Group 1: TR Band Arm
Patients will receive hemostatic compression using the current standard of care TR band (Terumo Corporation, Japan). The band will be applied according to the instructions for use, with optimal pressure applied using "Patent hemostasis protocol" to achieve full hemostasis.
Device: VasoBand
Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression

Active Comparator: Group 2: Vaso-band Arm
Patients will receive Vaso-band (VasoInnovations, Inc, USA), applied with ulnar balloon inflated with 15 ml of air, and the radial balloon inflated after the sheath is removed, to apply optimal pressure for obtaining full hemostasis. Ulnar balloon will be deflated after 60 minutes of radial artery hemostatic compression.
Device: VasoBand
Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression

Primary Outcome Measures :
  1. Patent hemostasis [ Time Frame: 0-15 minutes ]
    Patent hemostasis achievement at 0-15 minutes after onset of radial artery hemostatic compression

Secondary Outcome Measures :
  1. Radial artery occlusion [ Time Frame: 0-60 minutes ]
    Absence of Patency of radial artery at 1-hour after removal of hemostatic compression

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients referred for cardiac catheterization undergoing transradial access

Exclusion Criteria:

  • Previous ipsilateral radial artery cannulation, oral systemic anticoagulation therapy, thrombolytic therapy in the previous 7 days.

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 identifier (NCT number): NCT04002791

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Contact: Tejas M Patel, MD +91 9824030576

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Apex Heart Institute Recruiting
Ahmedabad, Gujarat, India
Contact: Tejas M Patel, MD   
Contact: Yash Soni   
Sponsors and Collaborators
Total Cardiovascular Solutions
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Principal Investigator: Tejas M Patel, MD Apex Heart Institute, Ahmedabad, India
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Responsible Party: Total Cardiovascular Solutions Identifier: NCT04002791    
Other Study ID Numbers: A98
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will be deidentified and will not be shared

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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.: Yes