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RAVE: Radial Artery Vascular Complication and Resource Utilization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522077
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
Chitogen, Inc.
Information provided by (Responsible Party):
Aurora Health Care

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.

Condition or disease Intervention/treatment Phase
Angiogram Percutaneous Coronary Intervention Device: RadAR EasyCLik plus ®-STF hemostatic pad Device: TR BAND® Compression device plus ®-STF hemostatic pad Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RAVE: Radial Artery Vascular Complication and Resource Utilization in Subjects Undergoing an Angiogram/PCI (Percutaneous Coronary Intervention)
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Arm Intervention/treatment
Experimental: RadAR EasyCLik plus SoftSeal®-STF hemostatic pad
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
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

Active Comparator: TR BAND® plus SoftSeal®-STF hemostatic pad
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
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




Primary Outcome Measures :
  1. Time to hemostasis [ Time Frame: 1 day ]
    Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis


Secondary Outcome Measures :
  1. Rate of acute radial artery occlusion [ Time Frame: 1 day ]
    Proportion of subjects who experience radial artery occlusion

  2. Major access site bleeding [ Time Frame: 1 day ]
    A ≥ 3 mg/dL drop in hemoglobin, or required blood transfusion or vascular repair to control bleeding

  3. Minor access site bleeding [ Time Frame: 1 day ]
    Light bleeding without hematoma formation

  4. Minor access site bleeding [ Time Frame: 30 days ]
    Light bleeding without hematoma formation

  5. Hematoma formation [ Time Frame: 1 day ]
    ≥ 3 cm in diameter

  6. Visual Analogue Scale (VAS) [ Time Frame: 1 day ]
    Pain at access site on numeric scale of 0-10

  7. Visual Analogue Scale (VAS) [ Time Frame: 30 days ]
    Pain at access site on numeric scale of 0-10

  8. Evidence of hand/digit ischemia [ Time Frame: 1 day ]
    Pain, tingling, or numbness in the hand and/or fingers reported

  9. Evidence of hand/digit ischemia [ Time Frame: 30 days ]
    Pain, tingling, or numbness in the hand and/or fingers reported

  10. Readmission [ Time Frame: 30 days ]
    Vascular complication

  11. Bruising, swelling, or redness [ Time Frame: 30 days ]
    At or near access site



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522077


Contacts
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Contact: Michelle Bennett, CAS 414-385-1889 Michelle.Bennett@aurora.org
Contact: Jennifer Cooper, RN, CCRC 414-385-2504 jennifer.cooper@aurora.org

Locations
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United States, Wisconsin
Aurora Health Care Recruiting
Milwaukee, Wisconsin, United States, 53202
Contact: Michelle Bennett    414-385-1889    Michelle.Bennett@aurora.org   
Principal Investigator: Muhammad F Jan, MD         
Sponsors and Collaborators
Aurora Health Care
Chitogen, Inc.
Investigators
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Principal Investigator: Muhammad F Jan, MD Aurora Health Care
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Responsible Party: Aurora Health Care
ClinicalTrials.gov Identifier: NCT03522077    
Other Study ID Numbers: 17-132
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Aurora Health Care:
Angiogram
Hemostatic
Activated clotting time
Quality of Life
Additional relevant MeSH terms:
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Hemostatics
Coagulants