RAVE: Radial Artery Vascular Complication and Resource Utilization

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Angiogram, Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: RadAR EasyCLik plus ®-STF hemostatic pad
* Device: TR BAND® Compression device plus ®-STF hemostatic pad
* Device: SoftSeal®-STF hemostatic pad
* Device: VascBand™ Hemostat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RadAR EasyCLik plus SoftSeal®-STF hemostatic pad<br>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. | Device: RadAR EasyCLik plus ®-STF hemostatic pad<br>* 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<br>|
| Active Comparator: TR BAND® plus SoftSeal®-STF hemostatic pad<br>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. | Device: TR BAND® Compression device plus ®-STF hemostatic pad<br>* 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<br>|
| Experimental: SoftSeal®-STF hemostatic<br>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. | Device: SoftSeal®-STF hemostatic pad<br>* Chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot<br>|
| Active Comparator: VascBand™ Hemostat<br>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. | Device: VascBand™ Hemostat<br>* The VascBand™ Hemostat is an FDA-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiogram, Hemostatic, Activated clotting time, Quality of Life