RAVE: Radial Artery Vascular Complication and Resource Utilization



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:10/10/2018
Start Date:May 9, 2018
End Date:December 1, 2019
Contact:Michelle Bennett, CAS
Email:Michelle.Bennett@aurora.org
Phone:414-385-1889

Use our guide to learn which trials are right for you!

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

The primary objective of this open label study is to compare the rate of vascular
complications associated with the use of the SoftSeal®-STF hemostatic pad in subjects
undergoing transradial catherization when compared to the VascBand™ Hemostat. Patients will
be randomized after radial access is achieved in 1:1 for each group.

The SoftSeal-STF hemostatic pad and VascBand Hemostat both 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.

The VascBand Hemostat is an FDA-approved compression device designed to assist hemostasis of
arterial, venous and hemodialysis percutaneous access sites. It does this by applying
pressure to stop bleeding.

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
We found this trial at
1
site
Milwaukee, Wisconsin 53215
Principal Investigator: Muhammad F Jan, MD
Phone: 414-385-1889
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials