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To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angio-Seal VIP Vascular Closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angio-Seal VIP 6 French (6F) and 8 French (8F) devices | Device | These devices are used for the vascular closure procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication | Major vascular complications include: Access Site Complications:
| 30 days post procedure |
| The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment. | within 5 minutes of device deployment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that will be included in the study will be indicated for the procedure according to the Instructions for Use. Physicians should carefully select patients based on the IFU including a consideration of all warnings and precautions.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerckhoff-Klinik GmbH | Bad Nauheim | Germany | ||||
| Institut für Diagnostiche und Interventionelle Radiologie |
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| ID | Title | Description |
|---|---|---|
| FG000 | Angio-Seal VIP Vascular Closure | Angio-Seal VIP 6 French (6F) and 8 French (8F) devices: These devices are used for the vascular closure procedure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Frankfurt |
| Germany |
| Univ. des Saarlandes | Homburg | Germany |
| Herzzentrum Leipzig GMBH | Leipzig | Germany |
| Amphia Ziekenhuis | Breda | Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| Device Deployment |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
All subects with deployed devices
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| ID | Title | Description |
|---|---|---|
| BG000 | Angio-Seal VIP Vascular Closure | Angio-Seal VIP 6F and 8F devices: These devices are used for the vascular closure procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 | The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication | Major vascular complications include: Access Site Complications:
| All subjects with device deployments. | Posted | Number | 95% Confidence Interval | % of subjects with MVCs | 30 days post procedure |
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| Primary | The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment. | Posted | Number | 95% Confidence Interval | % of proc. w/hemostasis within 5 min | within 5 minutes of device deployment | Procedures | Procedures |
|
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30 days
A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
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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 | Deployed Subjects | Adverse Events (AEs) are provided for all subjects that underwent a study device deployment. | 34 | 211 | 31 | 211 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
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| VASC bleeding | Vascular disorders | Systematic Assessment |
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| VASC pseudoaneurysm | Vascular disorders | Systematic Assessment |
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| Vascular Hematoma | Vascular disorders | Systematic Assessment |
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| Aortic Valve Stenosis | Cardiac disorders | Systematic Assessment |
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| Bacterial Infection | Infections and infestations | Systematic Assessment | Vascular Access Site Complication (VASC) Infections |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Aortic Aneurysm | Vascular disorders | Systematic Assessment |
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| Vascular Disection | Vascular disorders | Systematic Assessment | Coronary Site - Not Access Site |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | Systematic Assessment |
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| Decreased Left Ventricular Function | Cardiac disorders | Systematic Assessment |
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| Elective Cardiac Surgery | Cardiac disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Intracerebral Hemorrhage | Vascular disorders | Systematic Assessment |
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| Ischemic Stroke | Vascular disorders | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Sick Sinus Syndrome | Cardiac disorders | Systematic Assessment |
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| Sustained Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VASC bruise | Vascular disorders | Systematic Assessment |
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| VASC hematoma | Vascular disorders | Systematic Assessment |
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| VASC bleeding | Vascular disorders | Systematic Assessment |
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| VASC pain | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Campbell | St. Jude Medical | +1.651.756.5538 | acampbell2@sjm.com |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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