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The purpose of this clinical study is to assess device deployment characteristics and performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6 French device utilizing the SJM collagen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angio-Seal VIP | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angio-Seal VIP | Device | Vascular Closure Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device deployment characteristics and performance | Device Deployment Success and rationale for non-deployment, procedural circumstances present during deployment such as type of procedure and procedure duration, Time to hemostasis, and assessment of vascular complications prior to leaving the cath lab. Data will be summarized using descriptive statistics in addition to listings or summary data tables being provided. | At procedure |
| Adverse events (vascular complications) | Adverse events (vascular complications) out to 30 days post-procedure on patients who have undegone a diagnostic and/or interventional procedure. | Ongoing |
| Measure | Description | Time Frame |
|---|---|---|
| Time to hemostasis | The time elapsed from device deployment (cutting of the suture) to complete cessation of arterial bleeding, stratified as hemostasis in less than 1 minute, 1-5 minutes, or greater than 5 minutes. | |
| Rate of minor vascular complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Luedenscheid | Lüdenscheid | Germany |
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| Ongoing |