AngiogramNCT03522077
RAVE: Radial Artery Vascular Complication and Resource Utilization
A study testing RadAR EasyCLik plus ®-STF hemostatic pad, TR BAND® Compression device plus ®-STF hemostatic pad and SoftSeal®-STF hemostatic pad in people with Angiogram and Percutaneous Coronary Intervention, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiogram, Percutaneous Coronary Intervention
- What is being tested?
- RadAR EasyCLik plus ®-STF hemostatic pad, TR BAND® Compression device plus ®-STF hemostatic pad and SoftSeal®-STF hemostatic pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for an angiogram/PCI
- Planned transradial approach
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RAVE: Radial Artery Vascular Complication and Resource Utilization in Subjects Undergoing an Angiogram/PCI (Percutaneous Coronary Intervention)
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.
- Conditions
- Angiogram, Percutaneous Coronary Intervention
- Being tested
- RadAR EasyCLik plus ®-STF hemostatic pad, TR BAND® Compression device plus ®-STF hemostatic pad, SoftSeal®-STF hemostatic pad, VascBand™ Hemostat
- Keywords
- Angiogram, Hemostatic, Activated clotting time, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
VascBand™ HemostatDevice
The VascBand™ Hemostat is an FDA-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: VascBand™ Hemostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hemostasis
Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis
Measured: 1 day
Secondary outcomes (12)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: At time of follow up office visit, if done within 45 days post procedure
Number of Participants With Evidence of Hand/Digit Ischemia
Reported as pain, tingling, or numbness in the hand and/or fingers reported
Measured: 3 days
Number of Participants With Evidence of Hand/Digit Ischemia
Reported as pain, tingling, or numbness in the hand and/or fingers reported
Measured: 30 days
Number of Participants Who Had a Readmission
Number of Participants who had a Readmission for a Vascular complication
Measured: 30 days
Number of Participants With Bruising, Swelling, or Redness
Number of participants with bruising, swelling, or redness at or near access site
Measured: 30 days
Number of Participants Who Completed Patient Satisfaction Assessment
Reported as average, above average, or excellent satisfaction with procedure
Measured: At time of follow up office visit, if done within 45 days post procedure
Number of Participants With Level of Post Procedure Healing
Satisfaction with healing post procedure, reported as average, above average, or excellent
Measured: At time of follow up office visit, if done within 45 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start9 May 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AngiogramStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Chitogen, Inc.
- Responsible party
- Sponsor
- Investigators
- Muhammad F Jan, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522077
- Sponsor's protocol ID
- IRB00106906
- Other IDs
- 17-132
- Status last verified
- Jan 2023
- First submitted
- 30 Apr 2018
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAVE: Radial Artery Vascular Complication and Resource Utilization in Subjects Undergoing an Angiogram/PCI (Percutaneous Coronary Intervention)
- ClinicalTrials.gov ID
- NCT03522077
- Acronym / sponsor ID
- IRB00106906
- Conditions
- Angiogram, Percutaneous Coronary Intervention
- Keywords
- Angiogram, Hemostatic, Activated clotting time, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Chitogen, Inc.
- Study start
- 9 May 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Posted 9 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RadAR EasyCLik plus SoftSeal®-STF hemostatic pad | Experimental | Device: RadAR EasyCLik plus ®-STF hemostatic padHemostasis 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. |
| TR BAND® plus SoftSeal®-STF hemostatic pad | Active comparator | Device: TR BAND® Compression device plus ®-STF hemostatic padHemostasis 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. |
| SoftSeal®-STF hemostatic | Experimental | Device: SoftSeal®-STF hemostatic padHemostasis 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. |
| VascBand™ Hemostat | Active comparator | Device: VascBand™ HemostatHemostasis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for an angiogram/PCI
- Planned transradial approach
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadAR EasyCLik plus ®-STF hemostatic padChitosan-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 | RadAR EasyCLik plus SoftSeal®-STF hemostatic pad |
| TR BAND® Compression device plus ®-STF hemostatic padChitosan-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 | TR BAND® plus SoftSeal®-STF hemostatic pad |
| SoftSeal®-STF hemostatic padChitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot | Device | SoftSeal®-STF hemostatic |
| VascBand™ HemostatThe VascBand™ Hemostat is an FDA-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites. | Device | VascBand™ Hemostat |
Primary outcome
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
12 secondary outcomes
Number of Participants With Major Access Site Bleeding
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
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
Time frame: At time of follow up office visit, if done within 45 days post procedure
Number of Participants With Hematoma Formation
Time frame: 1 day
Visual Analogue Scale (VAS)
Time frame: 3 day
Visual Analogue Scale (VAS)
Time frame: At time of follow up office visit, if done within 45 days post procedure
Number of Participants With Evidence of Hand/Digit Ischemia
Time frame: 3 days
Number of Participants With Evidence of Hand/Digit Ischemia
Time frame: 30 days
Number of Participants Who Had a Readmission
Time frame: 30 days
Number of Participants With Bruising, Swelling, or Redness
Time frame: 30 days
Number of Participants Who Completed Patient Satisfaction Assessment
Time frame: At time of follow up office visit, if done within 45 days post procedure
Number of Participants With Level of Post Procedure Healing
Time frame: At time of follow up office visit, if done within 45 days post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad F Jan, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RadAR EasyCLik plus ®-STF hemostatic pad, TR BAND® Compression device plus ®-STF hemostatic pad and SoftSeal®-STF hemostatic pad in people with Angiogram and Percutaneous Coronary Intervention, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Hemostasis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.