LeMaitre® CARDIAL Dialine II Post Market Study

Completed

• Conditions: Vascular Occlusive Disease; Artery Injury; Vascular Aneurysm
• Interventions: Device: LeMaitre Cardial Dialine II

• Registration Number: NCT05350358
• Lead Sponsor: Geprovas

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-22
• Last Update Submitted: 2022-04-27
• Study First Posted: 2022-04-28
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who have undergone surgical treatment with LeMaitre Cardial Dialine II	LeMaitre Cardial Dialine II	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

GEPROVAS; 🇫🇷 Strasbourg, Bas-Rhin, France