Clinical trial NCT03522077: RAVE: Radial Artery Vascular Complication and Resource Utilization
Official title: RAVE: Radial Artery Vascular Complication and Resource Utilization in Subjects Undergoing an Angiogram/PCI (Percutaneous Coronary Intervention)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angiogram
Percutaneous Coronary Intervention
Keywords: Angiogram
Hemostatic
Activated clotting time
Quality of Life
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Chitogen, Inc.
First posted: 2018-05-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Hemostasis
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants With Major Access Site Bleeding
timeFrame: Post procedure to prior to discharge, on average same day discharge or up to 1-2 days
measure: Number of Participants With Minor Access Site Bleeding
timeFrame: Post procedure to prior to discharge, on average same day discharge or up to 1-2 days
measure: Number of Participants With Minor Access Site Bleeding
timeFrame: At time of follow up office visit, if done within 45 days post procedure
measure: Number of Participants With Hematoma Formation
timeFrame: 1 day
measure: Visual Analogue Scale (VAS)
timeFrame: 3 day
measure: Visual Analogue Scale (VAS)
timeFrame: At time of follow up office visit, if done within 45 days post procedure
measure: Number of Participants With Evidence of Hand/Digit Ischemia
timeFrame: 3 days
measure: Number of Participants With Evidence of Hand/Digit Ischemia
timeFrame: 30 days
measure: Number of Participants Who Had a Readmission
timeFrame: 30 days
measure: Number of Participants With Bruising, Swelling, or Redness
timeFrame: 30 days
measure: Number of Participants Who Completed Patient Satisfaction Assessment
timeFrame: At time of follow up office visit, if done within 45 days post procedure
measure: Number of Participants With Level of Post Procedure Healing
timeFrame: At time of follow up office visit, if done within 45 days post procedure
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Muhammad F Jan, MD
role: PRINCIPAL_INVESTIGATOR
References: