LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry

LeMaitre Vascular

Status: Completed

Conditions: Diseased or Occluded Blood Vessels; Arteriovenous Shunting for Blood Access

Treatments: Device: PVP; Device: AV Access

Study type: Observational

Funder types: Industry

Identifiers

NCT04620889

LFP-15-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 153 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

153 participants in 2 patient groups

PVP (peripheral vascular disease)

Description:

Bypass or reconstruction of diseased or occluded blood vessels

Treatment:

Device: PVP

AV Access (arteriovenous access)

Description:

Arteriovenous shunting for blood access and bypass.

Treatment:

Device: AV Access