RAVE: Radial Artery Vascular Complication and Resource Utilization

NCT ID: NCT03522077

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-09
• Study Completion Date: 2021-12-01

Brief Summary

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.

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.

Conditions

Angiogram; Percutaneous Coronary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RadAR EasyCLik plus ®-STF hemostatic pad

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

TR BAND® Compression device plus ®-STF hemostatic pad

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

SoftSeal®-STF hemostatic pad

Intervention Type: DEVICE

Chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot

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.

Group Type: ACTIVE_COMPARATOR

VascBand™ Hemostat

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

VascBand™ Hemostat

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chitogen, Inc.

INDIV

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad F Jan, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Aurora Health Care

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-132

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00106906

Identifier Type: -

Identifier Source: org_study_id