NCT03522077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

May 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 9, 2023

Completed
Last Updated

October 3, 2024

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

April 30, 2018

Results QC Date

November 28, 2022

Last Update Submit

October 1, 2024

Conditions

AngiogramPercutaneous Coronary Intervention

Keywords

AngiogramHemostaticActivated clotting timeQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Number of Participants With Major Access Site Bleeding

    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

    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

    At time of follow up office visit, if done within 45 days post procedure

  • Number of Participants With Hematoma Formation

    1 day

  • Visual Analogue Scale (VAS)

    3 day

  • +7 more secondary outcomes

Study Arms (4)

RadAR EasyCLik plus SoftSeal®-STF hemostatic pad

EXPERIMENTAL

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

TR BAND® plus SoftSeal®-STF hemostatic pad

ACTIVE COMPARATOR

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

SoftSeal®-STF hemostatic

EXPERIMENTAL

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

VascBand™ Hemostat

ACTIVE COMPARATOR

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

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

RadAR EasyCLik plus SoftSeal®-STF hemostatic pad
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

TR BAND® plus SoftSeal®-STF hemostatic pad
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

SoftSeal®-STF hemostatic
VascBand™ HemostatDEVICE

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

VascBand™ Hemostat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for an angiogram/PCI
  • Planned transradial approach

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurora Health Care

Milwaukee, Wisconsin, 53202, United States

Location

Limitations and Caveats

The limitations of our study are that only the first phase of the study was randomized. The second phase was nonrandomized, which could potentially cause bias in our study. However, we used a consecutive enrollment approach where the first 100 patients were scheduled for the SoftSeal + EasyClick approach, and the subsequent 100 patients were enrolled for SoftSeal + TR Band approach.

Results Point of Contact

Title
Dr. Muhammad Fuad Jan
Organization
Aurora Health Care
fuad.jan@aah.org
414-649-3491

Study Officials

  • Muhammad F Jan, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 11, 2018

Study Start

May 9, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 3, 2024

Results First Posted

February 9, 2023

Record last verified: 2023-01

Locations

US(1)