LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry

Study Overview
=================
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.

Official Title
-----------------
A Retrospective Patient Registry on the Long-Term Safety and Performance of the LifeSpan® ePTFE Vascular Graft Used in Open Vascular Surgery

Conditions
-----------------
Diseased or Occluded Blood Vessels, Arteriovenous Shunting for Blood Access

Intervention / Treatment
-----------------
* Device: AV Access
* Device: PVP


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PVP (peripheral vascular disease)<br>Bypass or reconstruction of diseased or occluded blood vessels | Device: PVP<br>* Bypass or reconstruction of diseased or occluded blood vessels<br>|
| AV Access (arteriovenous access)<br>Arteriovenous shunting for blood access and bypass. | Device: AV Access<br>* Arteriovenous shunting for blood access.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |