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

LeMaitre Vascular1 site in 1 country153 target enrollmentNovember 27, 2020

ConditionsDiseased or Occluded Blood Vessels Arteriovenous Shunting for Blood Access

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diseased or Occluded Blood Vessels
Sponsor: LeMaitre Vascular
Enrollment: 153
Locations: 1
Primary Endpoint: Percentage of vessels patent without requiring intervention to remain open
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 27, 2020

End Date

November 24, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

LeMaitre Vascular

Responsible Party

Sponsor

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

Not provided

Outcomes

Primary Outcomes

Percentage of vessels patent without requiring intervention to remain open

Time Frame: 2 years

Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up

Secondary Outcomes

Procedure type(Day of procedure)
Intra-operative technical success(Day of procedure)
Percentage of vessels patent without requiring intervention to remain open at 1 and 5 year primary patency(1 year and 5 year)
Percentage of vessels patent with intervention to remain open at 1 and 5 year for AV Access(2 year)
Percentage of vessels patent with intervention to remain open at 1 and 5 year for PVP Group(3 year)
Percentage of vessels patent with intervention to remain open at 1 and 5 year(1 year and 5 year)