Angio-Seal Interventional Radiology (IR) Registry

Study Overview
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Brief Summary
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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 Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations.

Official Title
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Clinical Registry of St. Jude Medical Angio-Seal™ Vascular Closure Devices Following Interventional Radiology Procedures

Conditions
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Diagnostic and/or Interventional Radiology Procedures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device. Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment. Exclusion Criteria: 1. Patients who are unable to provide written informed consent.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Angio-Seal<br>Angio-Seal attempted and/or deployed | |
| Not deployed<br>Other method of closure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means; Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention; Access site related bleeding requiring transfusion; New ipsilateral lower extremity ischemia requiring surgical intervention; Retroperitoneal bleeding; Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics; Access related complication that results in extended hospital stay; Death | 30 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Rate of Minor Vascular Complications | The following are defined as a minor vascular complication: Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis; Ipsilateral hematoma >10 cm; Ipsilateral pseudoaneurysm without intervention; Ipsilateral arteriovenous fistula; Ipsilateral deep vein thrombosis; Local access site infection without prolonged hospitalization | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular closure, Angio-Seal, Interventional radiology, femoral artery