RAVE: Radial Artery Vascular Complication and Resource Utilization

RAVE: Radial Artery Vascular Complication and Resource Utilization in Subjects Undergoing an Angiogram/PCI (Percutaneous Coronary Intervention)

The primary objective of this study is to determine if there is a reduction in time to hemostasis in subjects treated with SoftSeal®-STF hemostatic pad when used in conjunction with a vascular compression device after radial transcatheter procedure.

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention; Angiogram
• Intervention / Treatment: Device: RadAR EasyCLik plus ®-STF hemostatic pad; Device: TR BAND® Compression device plus ®-STF hemostatic pad; Device: SoftSeal®-STF hemostatic pad; Device: VascBand™ Hemostat

Detailed Description

The SoftSeal-STF hemostatic pad and compression devices (TR BAND® and RadAR EasyCLik) function to stop bleeding without obstructing radial artery flow, and have been shown to reduce the occurrence of radial artery occlusion.

The SoftSeal-STF hemostatic pad is an FDA-approved, chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot. Its mechanism of action is believed to be due to bioadhesion between the chitosan polymer chains, which are positively charged, and the negatively charged blood and tissue components, thereby stopping bleeding.

In this study the RadAR EasyCLik and TR BAND® Compression devices will be used with the SoftSeal®-STF hemostatic pad to promote hemostasis at the puncture site. Both vascular compression devices are FDA approved.

The VascBand™ Hemostat is an FDA-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53202
      • Aurora Health Care

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Scheduled for an angiogram/PCI
• Planned transradial approach

Exclusion Criteria:

• Evidence of impaired dual perfusion to the hand when tested using Allen's test
• Inaccessible radial arteries due to anatomic variations
• Infection or other skin disorder at the puncture site
• Undergoing an emergent or unplanned angiogram using the transradial approach
• Evidence of severe cognitive impairment or inability to understand the study procedures and answer follow-up questions
• Known sensitivity or allergic reaction to materials in the study devices
• Unwilling to participate in the study and follow all study-related procedures
• Participating physician deems the subject to not be a good candidate
• Inability to achieve radial access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RadAR EasyCLik plus SoftSeal®-STF hemostatic pad; Hemostasis will be obtained with the SoftSeal®-STF hemostatic pad and vascular compression device by applying pressure at the point proximal and distal to the puncture site and removing the sheath. While still maintaining pressure, the SoftSeal®-STF hemostatic pad will be applied over the puncture site. The cath lab staff will allow a small amount of blood (< 0.2 mL) to contact the surface of the hemostatic pad and then will apply constant pressure with a vascular compression device.	Device: RadAR EasyCLik plus ®-STF hemostatic pad; Chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot in conjunction with the RadAR EasyCLik compression device
Active Comparator: TR BAND® plus SoftSeal®-STF hemostatic pad; Hemostasis will be obtained with the SoftSeal®-STF hemostatic pad and vascular compression device by applying pressure at the point proximal and distal to the puncture site and removing the sheath. While still maintaining pressure, the SoftSeal®-STF hemostatic pad will be applied over the puncture site. The cath lab staff will allow a small amount of blood (< 0.2 mL) to contact the surface of the hemostatic pad and then will apply constant pressure with a vascular compression device.	Device: TR BAND® Compression device plus ®-STF hemostatic pad; Chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot in conjunction with the TR BAND® compression device
Experimental: SoftSeal®-STF hemostatic; Hemostasis at the radial access site for subjects randomized to the SoftSeal®-STF hemostatic pad will be obtained by applying pressure at the point proximal and distal to the puncture site and removing the sheath. While still maintaining pressure, the SoftSeal®-STF hemostatic pad will be applied over the puncture site. The cath lab staff will allow a small amount of blood (< 0.2 mL) to contact the surface of the hemostatic pad and then will apply constant pressure.	Device: SoftSeal®-STF hemostatic pad; Chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot
Active Comparator: VascBand™ Hemostat; Hemostasis at the radial access for subjects randomized to the VascBand™ Hemostat will be obtained in accordance to the manufacturer's instructions. The VascBand™ device will be placed proximal to the puncture site and inflated slowly while simultaneously removing the sheath, and continue to inject air (max. 18 mL) into the device until hemostasis is obtained.	Device: VascBand™ Hemostat; The VascBand™ Hemostat is an FDA-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hemostasis	Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Major Access Site Bleeding	A ≥ 3 mg/dL drop in hemoglobin, or required blood transfusion or vascular repair to control bleeding. Prior to discharge.	Post procedure to prior to discharge, on average same day discharge or up to 1-2 days
Number of Participants With Minor Access Site Bleeding	Number of participants with light access site bleeding without hematoma formation	Post procedure to prior to discharge, on average same day discharge or up to 1-2 days
Number of Participants With Minor Access Site Bleeding	Number of participants with light access site bleeding without hematoma formation	At time of follow up office visit, if done within 45 days post procedure
Number of Participants With Hematoma Formation	Number of participants with hematoma formation ≥ 3 cm in diameter	1 day
Visual Analogue Scale (VAS)	Pain at access site on numeric scale of 0-10, 0 meaning no pain at all and 10 meaning extreme pain. A lower score is a better outcome and higher score is a worse outcome.	3 day
Visual Analogue Scale (VAS)	Pain at access site on numeric scale of 0-10, 0 meaning no pain at all and 10 meaning extreme pain. A lower score is a better outcome and higher score is a worse outcome.	At time of follow up office visit, if done within 45 days post procedure
Number of Participants With Evidence of Hand/Digit Ischemia	Reported as pain, tingling, or numbness in the hand and/or fingers reported	3 days
Number of Participants With Evidence of Hand/Digit Ischemia	Reported as pain, tingling, or numbness in the hand and/or fingers reported	30 days
Number of Participants Who Had a Readmission	Number of Participants who had a Readmission for a Vascular complication	30 days
Number of Participants With Bruising, Swelling, or Redness	Number of participants with bruising, swelling, or redness at or near access site	30 days
Number of Participants Who Completed Patient Satisfaction Assessment	Reported as average, above average, or excellent satisfaction with procedure	At time of follow up office visit, if done within 45 days post procedure
Number of Participants With Level of Post Procedure Healing	Satisfaction with healing post procedure, reported as average, above average, or excellent	At time of follow up office visit, if done within 45 days post procedure

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Chitogen, Inc.
• Investigators: Principal Investigator: Muhammad F Jan, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2018
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Angiogram; Hemostatic; Activated clotting time
• Additional Relevant MeSH Terms: Coagulants; Hemostatics
• Other Study ID Numbers: IRB00106906; 17-132 (Aurora St Lukes Medical Center)

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