LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry

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

This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.

Study Overview

• Status: Active, not recruiting
• Conditions: Diseased or Occluded Blood Vessels; Arteriovenous Shunting for Blood Access
• Intervention / Treatment: Device: PVP; Device: AV Access

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 Type: Observational
• Enrollment (Estimated): 177

Contacts and Locations

• Study Contact: Name: Brian K Orrick; Phone Number: 781-425-1685; Email: jasmin.staewen@klinikum-nf.de

Study Locations

• Germany
  • Husum, Germany
    • Klinikum Nordfriesland GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective registry. The included population is therefore directly representative of the population in a real-world environment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

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

Collaborators and Investigators

• Sponsor: LeMaitre Vascular

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LFP-15-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a fully anonymized registry. No IPD will be collected or shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes