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

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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Aneurysm; Artery Injury; Vascular Occlusive Disease
• Intervention / Treatment: Device: LeMaitre Cardial Dialine II

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 Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• France
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67000
      • Geprovas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects who have 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who have undergone surgical treatment with 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.	Device: LeMaitre Cardial Dialine II; Surgical treatment for the replacement or bypass with LeMaitre Cardial Dialine II

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Geprovas
• Collaborators: LeMaitre Vascular
• Investigators: Principal Investigator: Nabil CHAKFE, PUPH-MD-PhD, Hôpitaux Universitaires de Strasbourg - GEPROVAS

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (ACTUAL): April 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Occlusion; Aneurysm; Arterial reconstruction; Vascular prosthesis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: DLN-41-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No