Patent Hemostasis With Vasoband Versus TR Band

NCT04002791 | Completed Results DMC FDA Device

• 1 other identifier: A98
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Radial Artery Injury at Wrist and Hand Level

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Achieved Patent Hemostasis

  Patent hemostasis achievement at 0-15 minutes after onset of radial artery hemostatic compression

  0-15 minutes

Secondary Outcomes (1)

• Number of Participants With Radial Artery Occlusion One Hour After Removal of Hemostatic Compression

  0-60 minutes

Study Arms (2)

Group 1: TR Band Arm

PLACEBO COMPARATOR

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

Group 2: Vaso-band Arm

ACTIVE COMPARATOR

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

Interventions

VasoBand DEVICE

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

Group 1: TR Band Arm; Group 2: Vaso-band Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for cardiac catheterization undergoing transradial access

You may not qualify if:

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

Sponsors & Collaborators

• Total Cardiovascular Solutions: lead

Study Sites (1)

Apex Heart Institute

Ahmedabad, Gujarat, India

Location

Limitations and Caveats

Single-center, single-country study

Results Point of Contact

• Title: Chairman
• Organization: Apex Heart Institute

theheartworld@gmail.com

011 91 9824030576

Study Officials

• Tejas M Patel, MD

  Apex Heart Institute, Ahmedabad, India

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized comparison of patent hemostasis achievement with single bladder radial artery compression device with a dual-bladder ulnar compression capable radial artery compression device.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: July 1, 2019
• Study Start: March 16, 2019
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: November 13, 2020
• Results First Posted: November 13, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)