LeMaitre® CARDIAL Dialine II Post Market Study

Vascular Aneurysm Clinical Trial

— Dialine II®  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05350358
• Other study ID #: DLN-41-001
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Geprovas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Artery Injury
• Vascular Aneurysm

Intervention

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

Locations

Country	Name	City	State
France	GEPROVAS	Strasbourg	Bas-Rhin

Sponsors (2)

Lead Sponsor	Collaborator
Geprovas	LeMaitre Vascular

Country where clinical trial is conducted

France, 

Outcome

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