Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT04002791
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
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

Show Show detailed description

Layout table for study information
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.


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

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 ClinicalTrials.gov identifier (NCT number): NCT04002791


Contacts
Layout table for location contacts
Contact: Tejas M Patel, MD +91 9824030576 theheartworld@gmail.com

Locations
Layout table for location information
India
Apex Heart Institute Recruiting
Ahmedabad, Gujarat, India
Contact: Tejas M Patel, MD       theheartworld@gmail.com   
Contact: Yash Soni       theheartworld@gmail.com   
Sponsors and Collaborators
Total Cardiovascular Solutions
Investigators
Layout table for investigator information
Principal Investigator: Tejas M Patel, MD Apex Heart Institute, Ahmedabad, India
Layout table for additonal information
Responsible Party: Total Cardiovascular Solutions
ClinicalTrials.gov 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

Layout table for additional information
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