LeMaitre® CARDIAL Dialine II Post Market Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05350358

Acronym

Dialine II®

Enrollment

262

Registered

2022-04-28

Start date

2021-03-01

Completion date

2021-12-31

Last updated

2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artery Injury, Vascular Aneurysm, Vascular Occlusive Disease

Keywords

Vascular prosthesis, Aneurysm, Occlusion, Arterial reconstruction

Brief summary

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.

Detailed description

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.

Interventions

DEVICELeMaitre Cardial Dialine II

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

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Primary patency of the prothesis	1 year
Occurence of serious adverse events	30 days after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026