RAVE: Radial Artery Vascular Complication and Resource Utilization

Not Applicable

Completed

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

• Registration Number: NCT03522077
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-04-30
• Study Start: 2018-05-09
• Study First Posted: 2018-05-11
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Results First Submitted: 2022-11-28
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-12
• Results First Posted: 2023-02-09
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Scheduled for an angiogram/PCI
• Planned transradial approach

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TR BAND® plus SoftSeal®-STF hemostatic pad	TR BAND® Compression device plus ®-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.
VascBand™ Hemostat	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.
RadAR EasyCLik plus SoftSeal®-STF hemostatic pad	RadAR EasyCLik plus ®-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.
SoftSeal®-STF hemostatic	SoftSeal®-STF hemostatic pad	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.

Primary Outcome Measures

Name	Time	Method
Time to Hemostasis	1 day	Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Minor Access Site Bleeding	At time of follow up office visit, if done within 45 days post procedure	Number of participants with light access site bleeding without hematoma formation
Number of Participants With Hematoma Formation	1 day	Number of participants with hematoma formation ≥ 3 cm in diameter
Number of Participants With Evidence of Hand/Digit Ischemia	30 days	Reported as pain, tingling, or numbness in the hand and/or fingers reported
Number of Participants With Bruising, Swelling, or Redness	30 days	Number of participants with bruising, swelling, or redness at or near access site
Number of Participants With Level of Post Procedure Healing	At time of follow up office visit, if done within 45 days post procedure	Satisfaction with healing post procedure, reported as average, above average, or excellent
Number of Participants Who Had a Readmission	30 days	Number of Participants who had a Readmission for a Vascular complication
Number of Participants Who Completed Patient Satisfaction Assessment	At time of follow up office visit, if done within 45 days post procedure	Reported as average, above average, or excellent satisfaction with procedure
Number of Participants With Major Access Site Bleeding	Post procedure to prior to discharge, on average same day discharge or up to 1-2 days	A ≥ 3 mg/dL drop in hemoglobin, or required blood transfusion or vascular repair to control bleeding. Prior to discharge.
Visual Analogue Scale (VAS)	At time of follow up office visit, if done within 45 days post procedure	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.

Trial Locations

Locations (1)

Aurora Health Care; 🇺🇸 Milwaukee, Wisconsin, United States