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NCT Number: NCT05350358

LeMaitre® CARDIAL Dialine II Post Market Study

This clinical study will capture clinical data specific to the performance and safety of the LeMaitre® CARDIAL Dialine II. It is a retrospective, monocenter, post-market safety and performance study. Following the new MDR regulation, this study will allow the clinical data of the prosthesis to be completed in order to renew its CE marking.

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Key information

Conditions

Vascular Aneurysm Aneurysm Artery Injury Bites and Stings Cardiovascular Diseases Chemically-Induced Disorders Poisoning Vascular Diseases Vascular Occlusive Disease Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GEPROVAS

Strasbourg, Bas-Rhin, 67000, France

About this study

The LeMaitre Cardial Dialine® II Vascular Prostheses (Dialine II) is a knitted PET (Polyethylene Terephthalate) graft manufactured with multifilament yarns and impregnated with bovine origin collagen to achieve a strong and dilatation resistant graft, which eliminates the preclotting step. The bovine collagen is then gradually resorbed by the patient. The Dialine II comes with black guide lines and crimped construction to facilitate implantation.

Other design features include:

  • Thin wall design (0.50+/-0.12mm) with excellent conformability
  • Special impregnation process for maximum leakage resistance
  • Water permeability < 10 ml/cm2/min

The Dialine II is indicated for replacement or bypass procedures in aneurysmal and/or occlusive diseases of the abdominal aorta or peripheral arteries. The Dialine II is also indicated for arterial reconstruction in patients requiring systemic heparinization. The unique collagen impregnation results in exceptional resistance to leakage, even under systemic heparinization.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female subjects, ≥ 18 years of age
  • Subject who has undergone surgical treatment for the replacement or bypass in aneurysmal and/or occlusive diseases and for arterial reconstruction in patients requiring systemic heparinization with LeMaitre Cardial Dialine II (between 01JAN2010 and 31JUL2016).

Exclusion criteria

  • Co-morbidity that in the discretion of the investigator might confound the results.
  • Patient operated on with a Dialine II Vascular prosthesis in conditions where it is connected with another one and that will make impossible to attribute the complication in the case it occurs
  • Infection that may affect the safety or the efficacity of the prothesis

Treatment and study plan

LeMaitre Cardial Dialine II

Device

Surgical treatment for the replacement or bypass with LeMaitre Cardial Dialine II

Primary outcomes

  1. Primary patency of the prothesis

    Time frame: 1 year

  2. Occurence of serious adverse events

    Time frame: 30 days after surgery

Sponsors and collaborators

Lead sponsor

Geprovas

Network

Collaborators

  • LeMaitre Vascular

Registry information

Official study title

A Retrospective Patient Registry on the Long-Term Performance of the Dialine II® Vascular Graft Prosthesis Used in Open Vascular Surgery

Acronym: Dialine II®

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2022
Registry last updated
May 3, 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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