Diseased or Occluded Blood Vessels, Arteriovenous Shunting for Blood Access
Conditions
Brief summary
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.
Detailed description
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.
Interventions
DEVICEAV Access
Arteriovenous shunting for blood access.
DEVICEPVP
Bypass or reconstruction of diseased or occluded blood vessels
Sponsors
LeMaitre Vascular
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject has undergone surgical treatment with the LifeSpan. * Surgical treatment was for bypass or reconstruction of diseased or occluded blood vessels (PVP group) or arteriovenous shunting for blood access (AV group). * For PVP group: Subject's surgical treatment was at minimum 3 years ago, and maximum 10 years ago, at time of enrollment. * For AV group: Subject's surgical treatment was at minimum 2 years ago, and maximum 10 years ago, at time of enrollment.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of vessels patent without requiring intervention to remain open | 3 years | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative technical success | Day of procedure | Percentage of patients with proper functioning of the device in the opinion of the investigator at time of surgery |
| Percentage of vessels patent without requiring intervention to remain open at 1 and 5 year primary patency | 1 year and 5 year | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up |
| Procedure type | Day of procedure | Type of procedure |
| Percentage of vessels patent with intervention to remain open at 1 and 5 year for AV Access | 2 year | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions |
| Percentage of vessels patent with intervention to remain open at 1 and 5 year for PVP Group | 3 year | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions |
| Percentage of vessels patent with intervention to remain open at 1 and 5 year | 1 year and 5 year | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions |
Countries
Germany
Outcome results
None listed