Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT05350358
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2022-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LeMaitre® CARDIAL Dialine II Post Market Study
Sponsor:
Geprovas
Organization:
Study Overview
Official Title:
A Retrospective Patient Registry on the Long-Term Performance of the Dialine II® Vascular Graft Prosthesis Used in Open Vascular Surgery
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: