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CompletedNCT03522077Updated Oct 3, 2024Results posted

RAVE: Radial Artery Vascular Complication and Resource Utilization

An interventional study of RadAR EasyCLik plus ®-STF hemostatic pad and TR BAND® Compression device plus ®-STF hemostatic pad in Angiogram and Percutaneous Coronary Intervention, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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

02

Conditions studied

  • Angiogram
  • Percutaneous Coronary Intervention

Keywords

  • Angiogram
  • Hemostatic
  • Activated clotting time
  • Quality of Life
03

In context

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.

Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.

Browse Wake Forest University Health Sciences studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Scheduled for an angiogram/PCI
  • Planned transradial approach

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • 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

  • 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

  • Experimental
    SoftSeal®-STF hemostatic

    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

  • Active comparator
    VascBand™ Hemostat

    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

  • DeviceRadAR 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

  • DeviceTR 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

  • DeviceSoftSeal®-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

  • DeviceVascBand™ Hemostat

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

06

What researchers measure

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

    Time frame: 1 day

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Number of Participants With Hematoma Formation

    Number of participants with hematoma formation ≥ 3 cm in diameter

    Time frame: 1 day

  5. 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

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

  7. Number of Participants With Evidence of Hand/Digit Ischemia

    Reported as pain, tingling, or numbness in the hand and/or fingers reported

    Time frame: 3 days

  8. Number of Participants With Evidence of Hand/Digit Ischemia

    Reported as pain, tingling, or numbness in the hand and/or fingers reported

    Time frame: 30 days

  9. Number of Participants Who Had a Readmission

    Number of Participants who had a Readmission for a Vascular complication

    Time frame: 30 days

  10. Number of Participants With Bruising, Swelling, or Redness

    Number of participants with bruising, swelling, or redness at or near access site

    Time frame: 30 days

  11. Number of Participants Who Completed Patient Satisfaction Assessment

    Reported as average, above average, or excellent satisfaction with procedure

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

  12. Number of Participants With Level of Post Procedure Healing

    Satisfaction with healing post procedure, reported as average, above average, or excellent

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

07

Results

Posted Feb 9, 2023
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.

Participant flow

Participant flow — Overall Study
MilestoneSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Started4951100100
Completed4951100100
Not completed0000

Outcome measures

PrimaryTime 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
Reported as:
Median · minutes
Time to Hemostasis
minutesSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Time to Hemostasis19 (15 to 30)120 (120 to 124)44 (40 to 58.5)45 (40 to 69)
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Major Access Site Bleeding
ParticipantsSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Number of Participants With Major Access Site Bleeding0000
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Minor Access Site Bleeding
ParticipantsSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Number of Participants With Minor Access Site Bleeding411220
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Minor Access Site Bleeding
ParticipantsSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Number of Participants With Minor Access Site Bleeding0000
SecondaryNumber of Participants With Hematoma Formation

Number of participants with hematoma formation ≥ 3 cm in diameter

Time frame:
1 day
Reported as:
Count of participants · Participants
Number of Participants With Hematoma Formation
ParticipantsSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Number of Participants With Hematoma Formation4025
SecondaryVisual 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
Reported as:
Mean · score on a scale
Visual Analogue Scale (VAS)
score on a scaleSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Visual Analogue Scale (VAS)0.94 ± 1.800.51 ± 1.290.38 ± 1.310.42 ± 1.27
SecondaryVisual 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:
At time of follow up office visit, if done within 45 days post procedure
Reported as:
Mean · score on a scale
Visual Analogue Scale (VAS)
score on a scaleSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Visual Analogue Scale (VAS)0.09 ± 0.350 ± 00 ± 00.03 ± 0.22
SecondaryNumber of Participants With Evidence of Hand/Digit Ischemia

Reported as pain, tingling, or numbness in the hand and/or fingers reported

Time frame:
3 days
Reported as:
Count of participants · Participants
Number of Participants With Evidence of Hand/Digit Ischemia
ParticipantsSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Number of Participants With Evidence of Hand/Digit Ischemia2000
SecondaryNumber of Participants With Evidence of Hand/Digit Ischemia

Reported as pain, tingling, or numbness in the hand and/or fingers reported

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Evidence of Hand/Digit Ischemia
ParticipantsSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Number of Participants With Evidence of Hand/Digit Ischemia0000
SecondaryNumber of Participants Who Had a Readmission

Number of Participants who had a Readmission for a Vascular complication

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants Who Had a Readmission
ParticipantsSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Number of Participants Who Had a Readmission0000
SecondaryNumber of Participants With Bruising, Swelling, or Redness

Number of participants with bruising, swelling, or redness at or near access site

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Bruising, Swelling, or Redness
ParticipantsSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Number of Participants With Bruising, Swelling, or Redness5356
SecondaryNumber of Participants Who Completed Patient Satisfaction Assessment

Reported as average, above average, or excellent satisfaction with procedure

Time frame:
At time of follow up office visit, if done within 45 days post procedure
Reported as:
Count of participants · Participants
Number of Participants Who Completed Patient Satisfaction Assessment
ParticipantsSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Average3144
Above average963420
Excellent33416076
No response4320
SecondaryNumber of Participants With Level of Post Procedure Healing

Satisfaction with healing post procedure, reported as average, above average, or excellent

Time frame:
At time of follow up office visit, if done within 45 days post procedure
Reported as:
Count of participants · Participants
Number of Participants With Level of Post Procedure Healing
ParticipantsSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Average4244
Above average653023
Excellent35416473
No response4320

Adverse events

Collected over Post procedure (considered time after procedure and prior to discharge), discharge (considered at time of discharge), 3 day follow up, and 30-45 day follow up office visit. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SoftSeal®-STF Hemostatic0/49 (0%)0/49 (0%)11/49 (22.4%)
VascBand™ Hemostat0/51 (0%)0/51 (0%)1/51 (2%)
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad0/100 (0%)0/100 (0%)13/100 (13%)
TR BAND® Plus SoftSeal®-STF Hemostatic Pad0/100 (0%)2/100 (2%)15/100 (15%)
Most frequent serious events
Most frequent serious events
EventSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
acute frontal intraparenchymal hemorrhage.Vascular disorders0/490/510/1001/100
Hematoma causing hospitalizationSkin and subcutaneous tissue disorders0/490/510/1001/100
Most frequent other events
Most frequent other events
EventSoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic Pad
Minor BleedingSurgical and medical procedures7/491/5111/10011/100
HematomaSurgical and medical procedures4/490/512/1004/100

Baseline characteristics

Age, Continuous
Age, Continuous(years)SoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic PadTotal
Median66 (58 to 72)65 (58 to 71)68 (58 to 74)65 (58 to 72)66 (58 to 73)
Sex: Female, Male
Sex: Female, Male(Participants)SoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic PadTotal
Female24183441117
Male25336659183
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic PadTotal
Hispanic or Latino11259
Not Hispanic or Latino48509895291
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic PadTotal
American Indian or Alaska Native00000
Asian00101
Native Hawaiian or Other Pacific Islander01001
Black or African American67111438
White43438886260
More than one race00000
Unknown or Not Reported00000
Hypertension
Hypertension(Participants)SoftSeal®-STF HemostaticVascBand™ HemostatRadAR EasyCLik Plus SoftSeal®-STF Hemostatic PadTR BAND® Plus SoftSeal®-STF Hemostatic PadTotal
Count of participants40458386254
08

Study locations

1 site
  • Aurora Health Care
    Milwaukee, Wisconsin 53202, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 11, 2021

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Dec 2021, 42 months.

Results were first posted in Feb 2023, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2018
First posted
May 11, 2018
StartActual
May 9, 2018
Primary completionActual
Dec 1, 2021
CompletionActual
Dec 1, 2021
Results first posted
Feb 9, 2023
Last update
Oct 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03522077
Lead sponsor
Wake Forest University Health Sciences
Collaborators
Chitogen, Inc.
Responsible party
Sponsor
First posted
May 11, 2018
Start date
May 9, 2018
Primary completion
Dec 1, 2021
Completion
Dec 1, 2021
Results posted
Feb 9, 2023
Last update
Oct 3, 2024

Study contacts

Muhammad F Jan, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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