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This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUMâ„¢ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SETALUMâ„¢ Sealant | Experimental | SETALUMâ„¢ Sealant to be applied on the suture line |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SETALUMâ„¢ Sealant | Device | SETALUMâ„¢ Sealant to be applied on the suture line |
|
| Measure | Description | Time Frame |
|---|---|---|
| Elapsed time from clamp release to hemostasis at the suture line | The hemostasis is observed by the operating surgeon and timed by an operative room nurse. Anastomotic hemostasis is defined as an anastomosis not requiring any additional intervention to control bleeding. | During surgical procedure |
| All adverse events occurring from the surgical procedure to Week 12 | Each Adverse Event was described by the seriouness and the nature of its relationship to the SETALUMâ„¢ Sealant or to the surgical procedure. The Data Monitoring Committee reviewed all occurred adverse events and provided a conclusion on the SETALUMâ„¢ Sealant safety profile. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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