VasoStat vs. TR Band for Radial Hemostasis

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Peripheral Arterial Disease
• Intervention / Treatment: Device: Radial artery mechanical compression for hemostasis

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)

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Montana
    • Missoula, Montana, United States, 59804
      • Billings Clinic Heart and Vascular at Community Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients referred for diagnostic or interventional arterial catheterization procedures who have coronary artery disease or peripheral artery disease

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VasoStat; Randomized to use of VasoStat radial mechanical compression for hemostasis device following sheath removal after transradial access for arterial catheterization procedures.	Device: Radial artery mechanical compression for hemostasis; 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.	Device: Radial artery mechanical compression for hemostasis; Transradial hemostasis following arterial catheterization procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of impact of two radial artery compression devices on hand perfusion measurements	Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter.	Perfusion index measurements day 1: before radial artery puncture, during wrist compression, after removal of compression device. Final perfusion index at 30-day followup appointment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of impact of two radial artery compression devices on hand perfusion prior to and during ulnar artery compression	Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter.	Perfusion index measurements on day 1 with ulnar compression: will include before radial artery puncture, and during wrist compression after radial sheath removal.
Patient satisfaction during use of wrist compression device	Survey of patient perception of wrist discomfort, hand numbness, pain, swelling and willingness to use again in the future	During application of radial artery mechanical compression
Hand perfusion and radial artery patency after one month	Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter. Duplex ultrasound will be used to assess radial artery patency.	30 day follow-up after use of mechanical wrist compression following transradial access for arterial catheterization procedures

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse outcomes	Hematoma, swelling, pain, paresthesia, arterial venous fistula, pseudoaneurysm, partial or total radial artery occlusion	During index hospital visit and at 30 day follow-up

Collaborators and Investigators

• Sponsor: Forge Medical
• Collaborators: Billings Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: VasoStat; TR Band; Transradial access; Coronary angiography; Peripheral arterial disease; Coronary artery disease; Peripheral angiography; Stents
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Peripheral Arterial Disease; Peripheral Vascular Diseases; Coagulants; Hemostatics
• Other Study ID Numbers: 20181194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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