VasoStat vs. TR Band for Radial Hemostasis

NCT ID: NCT04163471

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2019-05-01

Brief Summary

VasoStat vs. TR Band compression for Radial Artery Hemostasis Following Transradial Catheterization Without Prior Radial Artery Access

Detailed Description

Patients will be enrolled if they are scheduled to undergo a coronary or peripheral catheterization procedure involving the placement of a sheath (plastic tube) in the radial artery near the participants wrist. The purpose of this research is to compare two devices which make bleeding stop after the participants procedure is finished and the plastic tube is removed from the radial artery in the wrist. The two devices are called the VasoStat and the TR Band. Both of these devices are called hemostasis devices, which means they stop bleeding (hemostasis). Both devices are approved by the Food and Drug Administration (FDA) and are used throughout hospitals in the United States. The investigators will compare blood flow to the hand, and survey patients as to how comfortable these devices are, while they are being used to stop bleeding after the catheterization procedure.

Patients will be randomized to one device or the other as part of the study.

The investigators will noninvasively measure the blood flow to the hand by placing a soft plastic probe on the tip of the thumb called a plethysmography probe. This measurement only takes a few seconds and is painless. The investigators will measure before, after application and after removal & before patients are discharged. Thirty days later, patients will return for another measurement and to examine the radial artery with an ultrasound probe.

40 patients will be enrolled. Statistical analysis: Based on prior studies, The investigators will assume that the VasoStat produces a 30% reduction in hand perfusion during normal clinical use. The investigators assume the TR Band produces a 70% reduction in hand perfusion during normal clinical use. Using a two-sample test of proportions, with a Type I error of 5%, a power of 80%, and an anticipated drop-out rate of 10%, The investigators will need to enroll 40 patients (20 patients in each arm of the study) (StatMate 2.0, GraphPad Software, San Diego, CA)

Conditions

Coronary Artery Disease; Peripheral Arterial Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

VasoStat

Randomized to use of VasoStat radial mechanical compression for hemostasis device following sheath removal after transradial access for arterial catheterization procedures.

Radial artery mechanical compression for hemostasis

Intervention Type: DEVICE

Transradial hemostasis following arterial catheterization procedures

TR Band

Randomized to use of TR Band radial mechanical compression for hemostasis device following sheath removal after transradial access for arterial catheterization procedures.

Radial artery mechanical compression for hemostasis

Intervention Type: DEVICE

Transradial hemostasis following arterial catheterization procedures

Interventions

Radial artery mechanical compression for hemostasis

Transradial hemostasis following arterial catheterization procedures

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• no prior radial access

Exclusion Criteria

• Patients receiving concurrent investigational medications
• Cellulitis overlying radial artery
• Oral anticoagulation
• Patients receiving glycoprotein IIb/IIIa inhibitors
• Dementia
• Prisoners
• Institutionalized individuals
• Allergy to medical adhesive
• Radial sheath > 6 French (ID)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Billings Clinic

OTHER

Sponsor Role: collaborator

Forge Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Billings Clinic Heart and Vascular at Community Medical Center

Missoula, Montana, United States

Countries

United States

Other Identifiers

20181194

Identifier Type: -

Identifier Source: org_study_id