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RAVE: Radial Artery Vascular Complication and Resource Utilization

NCT03522077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-10-03

Study results available
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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.

Conditions

  • Angiogram
  • Percutaneous Coronary Intervention

Interventions

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

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

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

DEVICE

VascBand™ Hemostat

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

Sponsors & Collaborators

  • Chitogen, Inc.

    collaborator INDIV

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Muhammad F Jan, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2021-12-01
Completion
2021-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03522077 on ClinicalTrials.gov