LeMaitre® CARDIAL Dialine II Post Market Study

NCT05350358 | Completed

• 1 other identifier: DLN-41-001
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Aneurysm; Vascular Occlusive Disease; Artery Injury

Keywords

Vascular prosthesis; Aneurysm; Occlusion; Arterial reconstruction

Outcome Measures

Primary Outcomes (2)

• Primary patency of the prothesis

  1 year

• Occurence of serious adverse events

  30 days after surgery

Study Arms (1)

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

Interventions

LeMaitre Cardial Dialine II DEVICE

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

Patients who have undergone surgical treatment with LeMaitre Cardial Dialine II

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Geprovas: lead
• LeMaitre Vascular: collaborator

Study Sites (1)

GEPROVAS

Strasbourg, Bas-Rhin, 67000, France

Location

MeSH Terms

Conditions

Aneurysm; Bites and Stings

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Nabil CHAKFE, PUPH-MD-PhD

  Hôpitaux Universitaires de Strasbourg - GEPROVAS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

FR (1)