Angiogram, Percutaneous Coronary Intervention
Conditions
Keywords
Angiogram, Hemostatic, Activated clotting time, Quality of Life
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.
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.
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.
Sponsors
Chitogen, Inc.
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | 1 day | Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 light access site bleeding without hematoma formation |
| Number of Participants With Hematoma Formation | 1 day | Number of participants with hematoma formation ≥ 3 cm in diameter |
| Visual Analogue Scale (VAS) | 3 day | 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. |
| Number of Participants With Evidence of Hand/Digit Ischemia | 3 days | Reported as pain, tingling, or numbness in the hand and/or fingers reported |
| 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 | A ≥ 3 mg/dL drop in hemoglobin, or required blood transfusion or vascular repair to control bleeding. Prior to discharge. |
| Number of Participants With Bruising, Swelling, or Redness | 30 days | Number of participants with bruising, swelling, or redness at or near access site |
| Number of Participants Who Completed Patient Satisfaction Assessment | At time of follow up office visit, if done within 45 days post procedure | Reported as average, above average, or excellent satisfaction with procedure |
| Number of Participants With Level of Post Procedure Healing | At time of follow up office visit, if done within 45 days post procedure | Satisfaction with healing post procedure, reported as average, above average, or excellent |
| Number of Participants Who Had a Readmission | 30 days | Number of Participants who had a Readmission for a Vascular complication |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 49 |
| 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.
VascBand™ Hemostat: The VascBand™ Hemostat is an FDA-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites. | 51 |
| 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.
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 | 100 |
| 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.
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 | 100 |
| Total | 300 |
Baseline characteristics
| Characteristic | SoftSeal®-STF Hemostatic | VascBand™ Hemostat | RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Total |
|---|---|---|---|---|---|
| Age, Continuous | 66 years | 65 years | 68 years | 65 years | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 50 Participants | 98 Participants | 95 Participants | 291 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hypertension | 40 Participants | 45 Participants | 83 Participants | 86 Participants | 254 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 11 Participants | 14 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 43 Participants | 88 Participants | 86 Participants | 260 Participants |
| Sex: Female, Male Female | 24 Participants | 18 Participants | 34 Participants | 41 Participants | 117 Participants |
| Sex: Female, Male Male | 25 Participants | 33 Participants | 66 Participants | 59 Participants | 183 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 51 | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 11 / 49 | 1 / 51 | 13 / 100 | 15 / 100 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 | 0 / 100 | 2 / 100 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SoftSeal®-STF Hemostatic | Time to Hemostasis | 19 minutes |
| VascBand™ Hemostat | Time to Hemostasis | 120 minutes |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Time to Hemostasis | 44 minutes |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Time to Hemostasis | 45 minutes |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SoftSeal®-STF Hemostatic | Number of Participants Who Completed Patient Satisfaction Assessment | Average | 3 Participants |
| SoftSeal®-STF Hemostatic | Number of Participants Who Completed Patient Satisfaction Assessment | Above average | 9 Participants |
| SoftSeal®-STF Hemostatic | Number of Participants Who Completed Patient Satisfaction Assessment | Excellent | 33 Participants |
| SoftSeal®-STF Hemostatic | Number of Participants Who Completed Patient Satisfaction Assessment | No response | 4 Participants |
| VascBand™ Hemostat | Number of Participants Who Completed Patient Satisfaction Assessment | No response | 3 Participants |
| VascBand™ Hemostat | Number of Participants Who Completed Patient Satisfaction Assessment | Excellent | 41 Participants |
| VascBand™ Hemostat | Number of Participants Who Completed Patient Satisfaction Assessment | Above average | 6 Participants |
| VascBand™ Hemostat | Number of Participants Who Completed Patient Satisfaction Assessment | Average | 1 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants Who Completed Patient Satisfaction Assessment | Excellent | 60 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants Who Completed Patient Satisfaction Assessment | No response | 2 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants Who Completed Patient Satisfaction Assessment | Above average | 34 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants Who Completed Patient Satisfaction Assessment | Average | 4 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants Who Completed Patient Satisfaction Assessment | No response | 0 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants Who Completed Patient Satisfaction Assessment | Average | 4 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants Who Completed Patient Satisfaction Assessment | Above average | 20 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants Who Completed Patient Satisfaction Assessment | Excellent | 76 Participants |
Secondary
Number of Participants Who Had a Readmission
Number of Participants who had a Readmission for a Vascular complication
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal®-STF Hemostatic | Number of Participants Who Had a Readmission | 0 Participants |
| VascBand™ Hemostat | Number of Participants Who Had a Readmission | 0 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants Who Had a Readmission | 0 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants Who Had a Readmission | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal®-STF Hemostatic | Number of Participants With Bruising, Swelling, or Redness | 5 Participants |
| VascBand™ Hemostat | Number of Participants With Bruising, Swelling, or Redness | 3 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Bruising, Swelling, or Redness | 5 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Bruising, Swelling, or Redness | 6 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal®-STF Hemostatic | Number of Participants With Evidence of Hand/Digit Ischemia | 2 Participants |
| VascBand™ Hemostat | Number of Participants With Evidence of Hand/Digit Ischemia | 0 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Evidence of Hand/Digit Ischemia | 0 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Evidence of Hand/Digit Ischemia | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal®-STF Hemostatic | Number of Participants With Evidence of Hand/Digit Ischemia | 0 Participants |
| VascBand™ Hemostat | Number of Participants With Evidence of Hand/Digit Ischemia | 0 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Evidence of Hand/Digit Ischemia | 0 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Evidence of Hand/Digit Ischemia | 0 Participants |
Secondary
Number of Participants With Hematoma Formation
Number of participants with hematoma formation ≥ 3 cm in diameter
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal®-STF Hemostatic | Number of Participants With Hematoma Formation | 4 Participants |
| VascBand™ Hemostat | Number of Participants With Hematoma Formation | 0 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Hematoma Formation | 2 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Hematoma Formation | 5 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SoftSeal®-STF Hemostatic | Number of Participants With Level of Post Procedure Healing | Average | 4 Participants |
| SoftSeal®-STF Hemostatic | Number of Participants With Level of Post Procedure Healing | Above average | 6 Participants |
| SoftSeal®-STF Hemostatic | Number of Participants With Level of Post Procedure Healing | Excellent | 35 Participants |
| SoftSeal®-STF Hemostatic | Number of Participants With Level of Post Procedure Healing | No response | 4 Participants |
| VascBand™ Hemostat | Number of Participants With Level of Post Procedure Healing | Above average | 5 Participants |
| VascBand™ Hemostat | Number of Participants With Level of Post Procedure Healing | Excellent | 41 Participants |
| VascBand™ Hemostat | Number of Participants With Level of Post Procedure Healing | No response | 3 Participants |
| VascBand™ Hemostat | Number of Participants With Level of Post Procedure Healing | Average | 2 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Level of Post Procedure Healing | Excellent | 64 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Level of Post Procedure Healing | Above average | 30 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Level of Post Procedure Healing | No response | 2 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Level of Post Procedure Healing | Average | 4 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Level of Post Procedure Healing | No response | 0 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Level of Post Procedure Healing | Above average | 23 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Level of Post Procedure Healing | Average | 4 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Level of Post Procedure Healing | Excellent | 73 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal®-STF Hemostatic | Number of Participants With Major Access Site Bleeding | 0 Participants |
| VascBand™ Hemostat | Number of Participants With Major Access Site Bleeding | 0 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Major Access Site Bleeding | 0 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Major Access Site Bleeding | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal®-STF Hemostatic | Number of Participants With Minor Access Site Bleeding | 0 Participants |
| VascBand™ Hemostat | Number of Participants With Minor Access Site Bleeding | 0 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Minor Access Site Bleeding | 0 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Minor Access Site Bleeding | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal®-STF Hemostatic | Number of Participants With Minor Access Site Bleeding | 4 Participants |
| VascBand™ Hemostat | Number of Participants With Minor Access Site Bleeding | 1 Participants |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Minor Access Site Bleeding | 12 Participants |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Number of Participants With Minor Access Site Bleeding | 20 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SoftSeal®-STF Hemostatic | Visual Analogue Scale (VAS) | 0.09 score on a scale | Standard Deviation 0.35 |
| VascBand™ Hemostat | Visual Analogue Scale (VAS) | 0 score on a scale | Standard Deviation 0 |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Visual Analogue Scale (VAS) | 0 score on a scale | Standard Deviation 0 |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Visual Analogue Scale (VAS) | 0.03 score on a scale | Standard Deviation 0.22 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SoftSeal®-STF Hemostatic | Visual Analogue Scale (VAS) | 0.94 score on a scale | Standard Deviation 1.8 |
| VascBand™ Hemostat | Visual Analogue Scale (VAS) | 0.51 score on a scale | Standard Deviation 1.29 |
| RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad | Visual Analogue Scale (VAS) | 0.38 score on a scale | Standard Deviation 1.31 |
| TR BAND® Plus SoftSeal®-STF Hemostatic Pad | Visual Analogue Scale (VAS) | 0.42 score on a scale | Standard Deviation 1.27 |