LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-27

Study Completion Date

2023-11-24

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diseased or Occluded Blood Vessels Arteriovenous Shunting for Blood Access

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PVP (peripheral vascular disease)

Bypass or reconstruction of diseased or occluded blood vessels

PVP

Intervention Type DEVICE

Bypass or reconstruction of diseased or occluded blood vessels

AV Access (arteriovenous access)

Arteriovenous shunting for blood access and bypass.

AV Access

Intervention Type DEVICE

Arteriovenous shunting for blood access.

Interventions

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AV Access

Arteriovenous shunting for blood access.

Intervention Type DEVICE

PVP

Bypass or reconstruction of diseased or occluded blood vessels

Intervention Type DEVICE

Eligibility Criteria

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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.