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The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths via an antegrade approach.
Due to the growing adoption of antegrade femoral access and the use of VCDs to close these arteriotomies, it is important to collect performance and complication outcomes data related to this procedural variable. The aim of this registry is to consistently collect prospective data on procedural outcomes on antegrade access cases closed with the VASCADE VCS in a way that is consistent with the RESPECT Study design and the FDA-approved Instructions for Use (IFU).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiva Medical VASCADE VCS | Device | At the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis (TTH) | Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis. | Procedural, usually within 15 minutes of enrollment |
| Major Access Site Closure-related Complications | Patient incident rate of combined major access site closure-related complications through 30 days | Through 30 days +/- 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Ambulation (TTA) | Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site. | Prior to discharge, usually within 24 hours |
| Time to Discharge (TTD) |
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Inclusion Criteria:
Exclusion Criteria:
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Acceptable candidate for an elective, non-emergent ipsilateral peripheral interventional endovascular procedure via antegrade access of the femoral artery using a 5, 6 or 7 Fr introducer sheath
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| Name | Affiliation | Role |
|---|---|---|
| Mehdi Shishehbor, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | United States | ||
| North MS Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25740963 | Background | Hermiller JB, Leimbach W, Gammon R, Karas SP, Whitbourn RJ, Wong SC, Goswami N, McCabe J, Cavros NG, Paulus R, Naidu SS, Turi ZG. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol. 2015 Mar;27(3):129-36. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VASCADE VCS | The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VASCADE VCS | The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 (TTH) | Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis. | Posted | Mean | Standard Deviation | minutes | Procedural, usually within 15 minutes of enrollment |
|
|
30 days
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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 | VASCADE VCS | The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic osteomyelitis of ankle/foot | Infections and infestations | Non-systematic Assessment | Chronic osteomyelitis of ankle/foot |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access site arterial re-bleeding after initial hemostasis | Blood and lymphatic system disorders | Non-systematic Assessment | Access site arterial re-bleeding after initial hemostasis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terry Alverson, Director of Regulatory and Clinical | Cardiva Medical | 408-470-7119 | Terry_Alverson@cardivamedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 7, 2017 | Jan 3, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility. |
| Through hospital discharge, usually within 24 hours |
| Device Success | Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression. | Procedural, usually within 15 minutes of enrollment |
| Procedure Success | Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days. | Through 30 +/- 7 days |
| Minor Access Site Closure-related Complications | Patient incident rate of combined minor access site closure-related complications through 30 days | Through 30 +/- 7 days |
| Tupelo |
| Mississippi |
| 38801 |
| United States |
| Coastal Surgery Specialists | Wilmington | North Carolina | 28401 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| San Antonio Endovascular and Heart Institute | San Antonio | Texas | 78258 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI (Body Mass Index) | Mean | Standard Deviation | kg/m^2 |
|
|
| Primary | Major Access Site Closure-related Complications | Patient incident rate of combined major access site closure-related complications through 30 days | Posted | Count of Participants | Participants | Through 30 days +/- 7 days |
|
|
|
| Secondary | Time to Ambulation (TTA) | Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site. | Posted | Mean | Standard Deviation | hours | Prior to discharge, usually within 24 hours |
|
|
|
| Secondary | Time to Discharge (TTD) | Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility. | Posted | Mean | Standard Deviation | hours | Through hospital discharge, usually within 24 hours |
|
|
|
| Secondary | Device Success | Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression. | Posted | Count of Participants | Participants | Procedural, usually within 15 minutes of enrollment |
|
|
|
| Secondary | Procedure Success | Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days. | Posted | Count of Participants | Participants | Through 30 +/- 7 days |
|
|
|
| Secondary | Minor Access Site Closure-related Complications | Patient incident rate of combined minor access site closure-related complications through 30 days | Posted | Count of Participants | Participants | Through 30 +/- 7 days |
|
|
|
| 0 |
| 52 |
| 2 |
| 52 |
| 11 |
| 52 |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment | Anemia |
|
| Sepsis | Infections and infestations | Non-systematic Assessment | Sepsis |
|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment | Acute Kidney Injury |
|
|
| Residual hematoma < 6 cm | Blood and lymphatic system disorders | Non-systematic Assessment | Residual hematoma < 6 cm |
|
| Tissue tract oozing - prolonged | Infections and infestations | Non-systematic Assessment | Tissue tract oozing - prolonged |
|
| Pseudoaneurysm not requiring repair | Cardiac disorders | Non-systematic Assessment | Pseudoaneurysm not requiring repair |
|
| Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Bruising |
|
| Groin pain | Surgical and medical procedures | Non-systematic Assessment | Groin pain |
|
| Angina | Cardiac disorders | Non-systematic Assessment | Angina |
|
| Worsening PVD | Vascular disorders | Non-systematic Assessment | Worsening PVD |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment | Hypotension |
|
| Mechanical Fall | General disorders | Non-systematic Assessment | Mechanicall Fall |
|
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