NCT05350358

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
• Phase: —
• Study type: Observational
• Enrollment: 262 (actual)
• Sponsor: Geprovas · Network
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Aneurysm
• Vascular Occlusive Disease
• Artery Injury

Interventions

Type	Name	Description
DEVICE	LeMaitre Cardial Dialine II	Surgical treatment for the replacement or bypass with LeMaitre Cardial Dialine II

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2022-04-28
• Last updated: 2022-05-03

Locations

1 site across 1 country: France