Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search. Data will be captured retrospectively. Subjects will have been treated with the investigational device in the past and according to standard of care. Subjects will not be involved in any registry related procedures.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVP (peripheral vascular disease) | Bypass or reconstruction of diseased or occluded blood vessels |
| |
| AV Access (arteriovenous access) | Arteriovenous shunting for blood access and bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV Access | Device | Arteriovenous shunting for blood access. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of vessels patent without requiring intervention to remain open | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up | 3 years |
| Percentage of vessels patent without requiring intervention to remain open | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure type | Type of procedure | Day of procedure |
| Intra-operative technical success | Percentage of patients with proper functioning of the device in the opinion of the investigator at time of surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
This is a retrospective registry. The included population is therefore directly representative of the population in a real-world environment.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Nordfriesland GmbH | Husum | Germany |
This is a fully anonymized registry. No IPD will be collected or shared.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PVP |
| Device |
Bypass or reconstruction of diseased or occluded blood vessels |
|
| Day of procedure |
| Percentage of vessels patent without requiring intervention to remain open at 1 and 5 year primary patency | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up | 1 year and 5 year |
| Percentage of vessels patent with intervention to remain open at 1 and 5 year | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions | 1 year and 5 year |
| Percentage of vessels patent with intervention to remain open at 1 and 5 year for AV Access | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions | 2 year |
| Percentage of vessels patent with intervention to remain open at 1 and 5 year for PVP Group | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions | 3 year |