RAVE: Radial Artery Vascular Complication and Resource Utilization

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522077
• Other study ID #: 17-132
• Status: Completed
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2023
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angiogram
• Percutaneous Coronary Intervention

Intervention

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

Locations

Country	Name	City	State
United States	Aurora Health Care	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Aurora Health Care	Chitogen, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Hematoma Formation	Number of participants with hematoma formation = 3 cm in diameter	1 day
Secondary	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
Secondary	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
Secondary	Number of Participants With Evidence of Hand/Digit Ischemia	Reported as pain, tingling, or numbness in the hand and/or fingers reported	3 days
Secondary	Number of Participants With Evidence of Hand/Digit Ischemia	Reported as pain, tingling, or numbness in the hand and/or fingers reported	30 days
Secondary	Number of Participants Who Had a Readmission	Number of Participants who had a Readmission for a Vascular complication	30 days
Secondary	Number of Participants With Bruising, Swelling, or Redness	Number of participants with bruising, swelling, or redness at or near access site	30 days
Secondary	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
Secondary	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