LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PVP (peripheral vascular disease) Bypass or reconstruction of diseased or occluded blood vessels |
Device: PVP
Bypass or reconstruction of diseased or occluded blood vessels
|
| AV Access (arteriovenous access) Arteriovenous shunting for blood access and bypass. |
Device: AV Access
Arteriovenous shunting for blood access.
|
Outcome Measures
Primary Outcome Measures
- 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
- Percentage of vessels patent without requiring intervention to remain open [2 years]
Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up
Secondary Outcome Measures
- Procedure type [Day of procedure]
Type of procedure
- 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
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum Nordfriesland GmbH | Husum | Germany |
Sponsors and Collaborators
- LeMaitre Vascular
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LFP-15-001