NCT03522077

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2018-05-09
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2018-05-11
• Last updated: 2024-10-03
• Results posted: 2023-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study