Clinical trial NCT05350358: LeMaitre® CARDIAL Dialine II Post Market Study
Official title: A Retrospective Patient Registry on the Long-Term Performance of the Dialine II® Vascular Graft Prosthesis Used in Open Vascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Aneurysm
Vascular Occlusive Disease
Artery Injury
Keywords: Vascular prosthesis
Aneurysm
Occlusion
Arterial reconstruction
Lead sponsor: Geprovas
Sponsor class: NETWORK
Collaborators: name: LeMaitre Vascular
First posted: 2022-04-28
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary patency of the prothesis
timeFrame: 1 year
measure: Occurence of serious adverse events
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: GEPROVAS
state: Bas-Rhin
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg - GEPROVAS
name: Nabil CHAKFE, PUPH-MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: