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Completed

NCT Number: NCT05519826

A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis

The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.

the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.

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Key information

Conditions

Aneurysm Abdominal Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Arterial Disease Occlusive Arterial Occlusive Diseases Cardiovascular Diseases Peripheral Aneurysms Prothesis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must meet all the following inclusion criteria in order to be eligible for inclusion in the study:

Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death

Exclusion criteria

  • Patients who refused the collection of their personal data.

Treatment and study plan

Vascular surgery

Device

POLYMAILLE® EXTRA THIN vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease.

Abdominal vascular surgery includes aorto-iliac and/or aorto-femoral vascular repair, i.e. graft implantation with proximal anastomosis to abdominal aorta (supra and/or infra-renal).

Peripheral vascular surgery includes peripheral arteries repair, i.e. graft implantation with no aortic anastomosis, and/or extra-anatomic vascular repair such as axillo-femoral and/or crossover bypass (femoro-femoral and/or ilio-femoral) and/or femoro-popliteal bypass above the knee.

Primary outcomes

  1. Primary performance endpoint

    Time frame: 1 year

    primary patency rate

  2. Primary safety endpoint

    Time frame: 1 year

    limb salvage rate

Secondary outcomes

  1. Procedural success rate

    Time frame: 5 years

    • Ability to use with no need for replacement by another device and,
    • Effective vascular flow restoration after procedure and,
    • In case of aneurysm, exclusion of aneurysmal portion after procedure.

  2. Primary patency rate

    Time frame: 5 years

    patent grafts without any procedure or intervention of the conduit itself

  3. Primary assisted patency rate

    Time frame: 5 years

    rate of patent grafts, with or without procedure or intervention of the conduit itself after device implantation, such as endovascular balloon angioplasty or anastomotic revision, however with graft never thrombosed (graft occlusion)

  4. -Secondary patency rate

    Time frame: 5 years

    rate of patent grafts, with or without procedure or intervention of the conduit itself after device implantation, such as endovascular balloon angioplasty or anastomotic revision, lysis and/or thrombectomy

  5. Device Failure

    Time frame: 5 years

    • Uncontrolled blood leakage from device
    • Loss of structural integrity, e.g. rupture and/or exaggerated dilation (> 50 %)
    • Occlusion of the device
    • Total or partial replacement of the device required

  6. Mortality rate

    Time frame: 5 years

    freedom % from death

  7. Limb salvage rate

    Time frame: 5 years

    freedom % from target limb major amputation

  8. Adverse events

    Time frame: 5 years

    any documented adverse events, including anticipated (as listed in section 6.2) and non-anticipated adverse events

Sponsors and collaborators

Lead sponsor

Perouse Medical

Industry

Collaborators

  • Eclevar Medtech

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2022
Registry last updated
Aug 29, 2022

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.

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