RAVE: Radial Artery Vascular Complication and Resource Utilization

Advocate Aurora Health

Status: Completed

Conditions: Percutaneous Coronary Intervention; Angiogram

Treatments: Device: TR BAND® Compression device plus ®-STF hemostatic pad; Device: RadAR EasyCLik plus ®-STF hemostatic pad; Device: SoftSeal®-STF hemostatic pad; Device: VascBand™ Hemostat

Study type: Interventional

Funder types: Other

Identifiers

NCT03522077

17-132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

RadAR EasyCLik plus SoftSeal®-STF hemostatic pad

Experimental group

Description:

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.

Treatment:

Device: RadAR EasyCLik plus ®-STF hemostatic pad

TR BAND® plus SoftSeal®-STF hemostatic pad

Active Comparator group

Description:

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.

Treatment:

Device: TR BAND® Compression device plus ®-STF hemostatic pad

SoftSeal®-STF hemostatic

Experimental group

Description:

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.

Treatment:

Device: SoftSeal®-STF hemostatic pad

VascBand™ Hemostat

Active Comparator group

Description:

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.

Treatment:

Device: VascBand™ Hemostat