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This web based e-Registry will be international, multi-center and prospective. Silver Graft e-Registry to assess the long term clinical benefit of Silver Graft in an unselected patient population
To assess the long term clinical benefit of Silver Graft in an unselected patient population with Peripheral Artery Occlusive Disease (PAOD) fulfilling one of the the following criteria:
Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair.
or
Any suitable patient with an increased risk for early graft failure except those mentioned under (3). These may include
or
Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PAOD or aneurysms | Patients
Surgical reconstruction with defined Silver Graft vascular prosthesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical reconstruction | Procedure | In contrast to silver acetate impregnated vascular graft, Silver Graft can be immersed in an antibiotic containing solution prior to implantation. This practice should always be followed according to each participant's hospital guidelines and experience. The long term efficacy of the metallic silver coating will not be reduced. Common practice antibiotic co-medication before, during and after surgery needs to be documented but is at the discretion of each participating institution. Due to the registry character of this assessment, i.e. routine use of the investigational product, local antibiotics, e.g. dipping of the vascular graft into a rifampin solution is permissible. |
| Measure | Description | Time Frame |
|---|---|---|
| graft patency | 12-month patency assessed with duplex ultrasound | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from infection | assessed through clinical parameters, imaging (ultrasound, MRI, CT), bacterial cultures | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from perigraft fluid presence | assessed through imaging (ultrasound, MRI, CT) | 12 months |
Inclusion Criteria:
Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair.
Any suitable patient with an increased risk for early graft failure except those mentioned under (3). These may include
Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.
Exclusion Criteria:
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Patients with PAOD Fontaine classification > IIa Patients in need of aneurysm repair Patients in need of revisions, i.e. graft infections
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| Name | Affiliation | Role |
|---|---|---|
| Jörg Tautenhahn, MD | Klinikum Magdeburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Magdeburg | Magdeburg | 39130 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23508393 | Background | Zegelman M, Guenther G, Waliszewski M, Pukacki F, Stanisic MG, Piquet P, Passon M, Halloul Z, Tautenhahn J, Claey L, Agostinho C, Simici D, Doebrich D, Mueller C, Balzer K. Results from the International Silver Graft Registry for high-risk patients treated with a metallic-silver impregnated vascular graft. Vascular. 2013 Jun;21(3):137-47. doi: 10.1177/1708538113478773. | |
| 19698298 |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001807 | Blood Vessel Prosthesis |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Background |
| Zegelman M, Guenther G, Florek HJ, Orend KH, Zuehlke H, Liewald F, Storck M. Results from the first in man german pilot study of the silver graft, a vascular graft impregnated with metallic silver. Vascular. 2009 Jul-Aug;17(4):190-6. doi: 10.2310/6670.2009.00034. |