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| ID | Type | Description | Link |
|---|---|---|---|
| 17-132 | Other Identifier | Aurora St Lukes Medical Center |
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| Name | Class |
|---|---|
| Chitogen, Inc. | INDIV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RadAR EasyCLik plus ®-STF hemostatic pad | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis | Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad F Jan, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora Health Care | Milwaukee | Wisconsin | 53202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2021 |
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| 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. |
|
| TR BAND® Compression device plus ®-STF hemostatic pad | Device | 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 pad | Device | 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 | Device | The VascBand™ Hemostat is an FDA-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites. |
|
Number of participants with light access site bleeding without hematoma formation |
| 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 | 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 | 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. | 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. | 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 | 3 days |
| Number of Participants With Evidence of Hand/Digit Ischemia | Reported as pain, tingling, or numbness in the hand and/or fingers reported | 30 days |
| Number of Participants Who Had a Readmission | Number of Participants who had a Readmission for a Vascular complication | 30 days |
| Number of Participants With Bruising, Swelling, or Redness | Number of participants with bruising, swelling, or redness at or near access site | 30 days |
| Number of Participants Who Completed Patient Satisfaction Assessment | Reported as average, above average, or excellent satisfaction with procedure | 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 | At time of follow up office visit, if done within 45 days post procedure |
| FG001 | 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. |
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Hypertension | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Hemostasis | Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis | Posted | Median | Inter-Quartile Range | minutes | 1 day |
|
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| |||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | Post procedure to prior to discharge, on average same day discharge or up to 1-2 days |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Minor Access Site Bleeding | Number of participants with light access site bleeding without hematoma formation | Posted | Count of Participants | Participants | Post procedure to prior to discharge, on average same day discharge or up to 1-2 days |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Minor Access Site Bleeding | Number of participants with light access site bleeding without hematoma formation | Posted | Count of Participants | Participants | At time of follow up office visit, if done within 45 days post procedure |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hematoma Formation | Number of participants with hematoma formation ≥ 3 cm in diameter | Posted | Count of Participants | Participants | 1 day |
| ||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 day |
| |||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | score on a scale | At time of follow up office visit, if done within 45 days post procedure |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Evidence of Hand/Digit Ischemia | Reported as pain, tingling, or numbness in the hand and/or fingers reported | Posted | Count of Participants | Participants | 3 days |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Evidence of Hand/Digit Ischemia | Reported as pain, tingling, or numbness in the hand and/or fingers reported | Posted | Count of Participants | Participants | 30 days |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Had a Readmission | Number of Participants who had a Readmission for a Vascular complication | Posted | Count of Participants | Participants | 30 days |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Bruising, Swelling, or Redness | Number of participants with bruising, swelling, or redness at or near access site | Posted | Count of Participants | Participants | 30 days |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Completed Patient Satisfaction Assessment | Reported as average, above average, or excellent satisfaction with procedure | Posted | Count of Participants | Participants | At time of follow up office visit, if done within 45 days post procedure |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Level of Post Procedure Healing | Satisfaction with healing post procedure, reported as average, above average, or excellent | Posted | Count of Participants | Participants | At time of follow up office visit, if done within 45 days post procedure |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 49 | 0 | 49 | 11 | 49 |
| EG001 | 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. | 0 | 51 | 0 | 51 | 1 | 51 |
| EG002 | 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 | 0 | 100 | 0 | 100 | 13 | 100 |
| EG003 | 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 | 0 | 100 | 2 | 100 | 15 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute frontal intraparenchymal hemorrhage. | Vascular disorders | Systematic Assessment |
| ||
| Hematoma causing hospitalization | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor Bleeding | Surgical and medical procedures | Systematic Assessment |
| ||
| Hematoma | Surgical and medical procedures | Systematic Assessment |
|
The limitations of our study are that only the first phase of the study was randomized. The second phase was nonrandomized, which could potentially cause bias in our study. However, we used a consecutive enrollment approach where the first 100 patients were scheduled for the SoftSeal + EasyClick approach, and the subsequent 100 patients were enrolled for SoftSeal + TR Band approach.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Muhammad Fuad Jan | Aurora Health Care | 414-649-3491 | fuad.jan@aah.org |
| Nov 28, 2022 |
| Prot_SAP_000.pdf |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 |
| 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
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| OG002 | 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 |
| OG003 | 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 |
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| OG002 | 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 |
| OG003 | 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 |
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| OG002 | 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 |
| OG003 | 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 |
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| OG002 |
| 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 |
| OG003 | 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 |
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| OG002 | 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 |
| OG003 | 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 |
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| OG002 | 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 |
| OG003 | 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 |
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| OG002 | 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 |
| OG003 | 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 |
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