Status:
COMPLETED
LeMaitre® CARDIAL Dialine II Post Market Study
Lead Sponsor:
Geprovas
Collaborating Sponsors:
LeMaitre Vascular
Conditions:
Vascular Aneurysm
Vascular Occlusive Disease
Eligibility:
All Genders
18-99 years
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. ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT05350358
Start Date
March 1 2021
End Date
December 31 2021
Last Update
May 3 2022
Active Locations (1)
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1
GEPROVAS
Strasbourg, Bas-Rhin, France, 67000