RAVE: Radial Artery Vascular Complication and Resource Utilization

N/ACompletedNCT03522077

Wake Forest University Health Sciences300 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Angiogram Percutaneous Coronary Intervention

Interventions

RadAR EasyCLik plus ®-STF hemostatic padDEVICE

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 padDEVICE

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 padDEVICE

Chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Aurora Health Care

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Time to Hemostasis

Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis

Time frame: 1 day

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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