LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry

Completed

• Conditions: Diseased or Occluded Blood Vessels; Arteriovenous Shunting for Blood Access
• Interventions: Device: PVP; Device: AV Access

• Registration Number: NCT04620889
• Lead Sponsor: LeMaitre Vascular

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.

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Study Start: 2020-11-27
• Primary Completion: 2023-11-24
• Study Completion: 2023-11-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PVP (peripheral vascular disease)	PVP	Bypass or reconstruction of diseased or occluded blood vessels
AV Access (arteriovenous access)	AV Access	Arteriovenous shunting for blood access and bypass.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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

Trial Locations

Locations (1)

Klinikum Nordfriesland GmbH; 🇩🇪 Husum, Germany