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LeMaitre® CARDIAL Dialine II Post Market Study

NCT05350358 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 262

Last updated 2022-05-03

No results posted yet for this study

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

Interventions

DEVICE

LeMaitre Cardial Dialine II

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

Sponsors & Collaborators

  • LeMaitre Vascular

    collaborator INDUSTRY

  • Geprovas

    lead NETWORK

Principal Investigators

  • Nabil CHAKFE, PUPH-MD-PhD · Hôpitaux Universitaires de Strasbourg - GEPROVAS

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350358 on ClinicalTrials.gov