LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry

N/ACompletedNCT04620889

LeMaitre Vascular153 enrolled

Overview

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

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

153

Conditions

Diseased or Occluded Blood Vessels Arteriovenous Shunting for Blood Access

Interventions

AV AccessDEVICE

Arteriovenous shunting for blood access.

PVPDEVICE

Bypass or reconstruction of diseased or occluded blood vessels

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Klinikum Nordfriesland GmbH

Husum, Germany

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 2 years

Secondary Outcomes

Procedure type

Type of procedure

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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