Trial Outcomes & Findings for RAVE: Radial Artery Vascular Complication and Resource Utilization (NCT NCT03522077)
NCT ID: NCT03522077
Last Updated: 2024-10-03
Results Overview
Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
1 day
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
100
|
100
|
|
Overall Study
COMPLETED
|
49
|
51
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RAVE: Radial Artery Vascular Complication and Resource Utilization
Baseline characteristics by cohort
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=99 Participants
|
65 years
n=107 Participants
|
68 years
n=206 Participants
|
65 years
n=7 Participants
|
66 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
117 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
183 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
291 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
260 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Hypertension
|
40 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
254 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1 dayTime interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Time to Hemostasis
|
19 minutes
Interval 15.0 to 30.0
|
120 minutes
Interval 120.0 to 124.0
|
44 minutes
Interval 40.0 to 58.5
|
45 minutes
Interval 40.0 to 69.0
|
SECONDARY outcome
Timeframe: Post procedure to prior to discharge, on average same day discharge or up to 1-2 daysA ≥ 3 mg/dL drop in hemoglobin, or required blood transfusion or vascular repair to control bleeding. Prior to discharge.
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Major Access Site Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post procedure to prior to discharge, on average same day discharge or up to 1-2 daysNumber of participants with light access site bleeding without hematoma formation
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Minor Access Site Bleeding
|
4 Participants
|
1 Participants
|
12 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: At time of follow up office visit, if done within 45 days post procedureNumber of participants with light access site bleeding without hematoma formation
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Minor Access Site Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 dayNumber of participants with hematoma formation ≥ 3 cm in diameter
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Hematoma Formation
|
4 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 dayPain 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.
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=48 Participants
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
|
VascBand™ Hemostat
n=47 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS)
|
0.94 score on a scale
Standard Deviation 1.80
|
0.51 score on a scale
Standard Deviation 1.29
|
0.38 score on a scale
Standard Deviation 1.31
|
0.42 score on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: At time of follow up office visit, if done within 45 days post procedurePain 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.
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=46 Participants
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
|
VascBand™ Hemostat
n=48 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=99 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS)
|
0.09 score on a scale
Standard Deviation 0.35
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0.03 score on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 3 daysReported as pain, tingling, or numbness in the hand and/or fingers reported
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Evidence of Hand/Digit Ischemia
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysReported as pain, tingling, or numbness in the hand and/or fingers reported
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Evidence of Hand/Digit Ischemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of Participants who had a Readmission for a Vascular complication
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Number of Participants Who Had a Readmission
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of participants with bruising, swelling, or redness at or near access site
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Bruising, Swelling, or Redness
|
5 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At time of follow up office visit, if done within 45 days post procedureReported as average, above average, or excellent satisfaction with procedure
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Number of Participants Who Completed Patient Satisfaction Assessment
Average
|
3 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Who Completed Patient Satisfaction Assessment
Above average
|
9 Participants
|
6 Participants
|
34 Participants
|
20 Participants
|
|
Number of Participants Who Completed Patient Satisfaction Assessment
Excellent
|
33 Participants
|
41 Participants
|
60 Participants
|
76 Participants
|
|
Number of Participants Who Completed Patient Satisfaction Assessment
No response
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At time of follow up office visit, if done within 45 days post procedureSatisfaction with healing post procedure, reported as average, above average, or excellent
Outcome measures
| Measure |
SoftSeal®-STF Hemostatic
n=49 Participants
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
|
VascBand™ Hemostat
n=51 Participants
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Level of Post Procedure Healing
Excellent
|
35 Participants
|
41 Participants
|
64 Participants
|
73 Participants
|
|
Number of Participants With Level of Post Procedure Healing
No response
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Level of Post Procedure Healing
Average
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Level of Post Procedure Healing
Above average
|
6 Participants
|
5 Participants
|
30 Participants
|
23 Participants
|
Adverse Events
SoftSeal®-STF Hemostatic
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
VascBand™ Hemostat
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SoftSeal®-STF Hemostatic
n=49 participants at risk
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
|
VascBand™ Hemostat
n=51 participants at risk
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 participants at risk
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 participants at risk
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
|
|---|---|---|---|---|
|
Vascular disorders
acute frontal intraparenchymal hemorrhage.
|
0.00%
0/49 • 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
|
0.00%
0/51 • 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
|
0.00%
0/100 • 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
|
1.0%
1/100 • 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
|
|
Skin and subcutaneous tissue disorders
Hematoma causing hospitalization
|
0.00%
0/49 • 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
|
0.00%
0/51 • 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
|
0.00%
0/100 • 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
|
1.0%
1/100 • 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
|
Other adverse events
| Measure |
SoftSeal®-STF Hemostatic
n=49 participants at risk
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
|
VascBand™ Hemostat
n=51 participants at risk
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.
|
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad
n=100 participants at risk
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
|
TR BAND® Plus SoftSeal®-STF Hemostatic Pad
n=100 participants at risk
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
|
|---|---|---|---|---|
|
Surgical and medical procedures
Minor Bleeding
|
14.3%
7/49 • 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
|
2.0%
1/51 • 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
|
11.0%
11/100 • 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
|
11.0%
11/100 • 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
|
|
Surgical and medical procedures
Hematoma
|
8.2%
4/49 • 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
|
0.00%
0/51 • 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
|
2.0%
2/100 • 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
|
4.0%
4/100 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place