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| Name | Class |
|---|---|
| LeMaitre Vascular | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LeMaitre Cardial Dialine II | Device | Surgical treatment for the replacement or bypass with LeMaitre Cardial Dialine II |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency of the prothesis | 1 year | |
| Occurence of serious adverse events | 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nabil CHAKFE, PUPH-MD-PhD | Hôpitaux Universitaires de Strasbourg - GEPROVAS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GEPROVAS | Strasbourg | Bas-Rhin | 67000 | France |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| D014947 |
| Wounds and Injuries |