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Completed

NCT Number: NCT04620889

LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry

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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Key information

Conditions

Diseased or Occluded Blood Vessels Arteriovenous Shunting for Blood Access

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Nordfriesland GmbH

Husum, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AV Access

Device

Arteriovenous shunting for blood access.

PVP

Device

Bypass or reconstruction of diseased or occluded blood vessels

Primary outcomes

  1. Percentage of vessels patent without requiring intervention to remain open

    Time frame: 3 years

    Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up

  2. Percentage of vessels patent without requiring intervention to remain open

    Time frame: 2 years

    Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up

Secondary outcomes

  1. Procedure type

    Time frame: Day of procedure

    Type of procedure

  2. Intra-operative technical success

    Time frame: Day of procedure

    Percentage of patients with proper functioning of the device in the opinion of the investigator at time of surgery

  3. Percentage of vessels patent without requiring intervention to remain open at 1 and 5 year primary patency

    Time frame: 1 year and 5 year

    Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up

  4. Percentage of vessels patent with intervention to remain open at 1 and 5 year

    Time frame: 1 year and 5 year

    Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions

  5. Percentage of vessels patent with intervention to remain open at 1 and 5 year for AV Access

    Time frame: 2 year

    Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions

  6. Percentage of vessels patent with intervention to remain open at 1 and 5 year for PVP Group

    Time frame: 3 year

    Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions

Sponsors and collaborators

Lead sponsor

LeMaitre Vascular

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2020
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.