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The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Sealâ„¢ Evolutionâ„¢ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angio-Seal | Angio-Seal attempted and/or deployed | ||
| Not deployed | Other method of closure |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Vascular Complications | Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure. The following are defined as a major vascular complication:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis | Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved >5 minutes and/or with additional hemostasis methods required. | Procedure |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients who are unable to provide written informed consent.
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Patients who undergo a diagnostic and/or interventional radiology procedure through percutaneous femoral artery access and meet the registry selection criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Zoltan Turi, M.D. | Cooper University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States | ||
| Yale New Haven Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
| 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 | Rate of Major Vascular Complications | Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure. The following are defined as a major vascular complication:
| 5 subjects underwent vascular closure with Angio-Seal on right and left sides. | Posted | Number | Percentage of Procedures | 30 days | Procedures | Procedures |
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 | All Participants |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular injury requiring repair via surgery or other means | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ipsilateral hematoma >10cm | Vascular disorders | Systematic Assessment |
Major and minor vascular complications were collected as Serious Adverse Event and Other Adverse Events as defined in the protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Campbell | St Jude Medical | 651-756-5538 | acampbell2@sjm.com |
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| Rate of Minor Vascular Complications | The following are defined as a minor vascular complication:
| 30 days |
| Impact of Guided Access on Use of Closure Device. | The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device. | 30 days |
| Impact of Guided Access on Achieving Target Puncture Location. | The influence of fluoroscopy and/or ultrasound guided access on puncture location. | 30 days |
| Rate of Major Vascular Complications (MVCs) by Guided Access Mode. | The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs). | 30 days |
| Rate of Minor Vascular Complications by Guided Access Mode. | The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications. | 30 days |
| Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device | Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device | 30 days |
| Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device | Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved. | 30 days |
| Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD) | Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC). | 30 days |
| Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD) | Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications. | 30 days |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Baptist Cardiac and Vascular Institute | Miami | Florida | 33176 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Kaleida Health | Buffalo | New York | 14209 | United States |
| Mayfield Clinic, Inc.; The University Hospital | Cincinnati | Ohio | 45219 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Thomas Jefferson Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Angio -Seal | Angio-Seal attempted and/or deployed group |
|
|
| Secondary | Time to Hemostasis | Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved >5 minutes and/or with additional hemostasis methods required. | Posted | Number | % of procedures | Procedure | Procedures | Procedures |
|
|
|
| Secondary | Rate of Minor Vascular Complications | The following are defined as a minor vascular complication:
| Posted | Number | % of procedures with minor vasc comp. | 30 days | Procedures | Procedures |
|
|
|
| Secondary | Impact of Guided Access on Use of Closure Device. | The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device. | Percentage of procedures with devices deployed | Posted | Number | % of procedures using a closure device | 30 days | Procedures | Procedures |
|
|
|
| Secondary | Impact of Guided Access on Achieving Target Puncture Location. | The influence of fluoroscopy and/or ultrasound guided access on puncture location. | Deployed subjects with readable angiograms | Posted | Number | % within target zone | 30 days |
|
|
|
| Secondary | Rate of Major Vascular Complications (MVCs) by Guided Access Mode. | The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs). | Posted | Number | % of procedures with MVCs | 30 days | Procedures | Procedures |
|
|
|
| Secondary | Rate of Minor Vascular Complications by Guided Access Mode. | The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications. | Posted | Number | % of procedures with minor vasc comp. | 30 days | Procedures | Procedures |
|
|
|
| Secondary | Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device | Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device | Posted | Number | % of procedures using closure device | 30 days | Procedures | Procedures |
|
|
|
| Secondary | Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device | Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved. | Posted | Number | % of procedures achieving hemostasis | 30 days | Procedures | Procedures |
|
|
|
| Secondary | Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD) | Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC). | Posted | Number | % of procedures with MVCs | 30 days | Procedures | Procedures |
|
|
|
| Secondary | Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD) | Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications. | Posted | Number | % of procedures with minor vasc comp. | 30 days | Procedures | Procedures |
|
|
|
| 15 |
| 634 |
| 4 |
| 634 |
| New ipsilateral lower extremity ischemia requiring intervention | Vascular disorders | Systematic Assessment |
|
| Retroperitoneal bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Neither fluoro nor ultrasound, n=156 procedures |
|
|
| Neither fluoro nor ultrasound, n=92 participants |
|
| Title | Measurements |
|---|---|
|
| Neither fluoro nor ultrasound, n=115 procedures |
|
| Title | Measurements |
|---|---|
|
| Neither fluoro nor ultrasound, n=115 procedures |
|