LeMaitre® CARDIAL Dialine II Post Market Study (Dialine II®)

Geprovas

Status: Completed

Conditions: Vascular Occlusive Disease; Artery Injury; Vascular Aneurysm

Treatments: Device: LeMaitre Cardial Dialine II

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05350358

DLN-41-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 262 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

262 participants in 1 patient group

Patients who have undergone surgical treatment with LeMaitre Cardial Dialine II

Description:

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.

Treatment:

Device: LeMaitre Cardial Dialine II