Silver Graft All Comers Registry

Study Overview
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Brief Summary
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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

Detailed Description
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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 diabetics Fontaine class> IIb patients of advanced age (≥75 y) patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l) patients with COPD or documented coronary artery disease (prior PCI, prior CABG, documented myocardial ischemia) patients with major amputation immunosuppressed patients patients with autoimmune disease, malignancy or Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.

Official Title
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Silver Graft All Comers Registry is to Assess the Long Term Clinical Benefit of Silver Graft in an Unselected Patient Population

Conditions
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Aneurysm, Graft Failure, Graft Infection

Intervention / Treatment
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* Procedure: Surgical reconstruction


Participation Criteria
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Eligibility Criteria
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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 diabetics Fontaine class> IIb patients of advanced age (≥75 y) patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l) patients with COPD or documented coronary artery disease (prior PCI, prior CABG, documented myocardial ischemia) patients with major amputation immunosuppressed patients patients with autoimmune disease, malignancy Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction. Exclusion Criteria: Any patient with common contraindications for vascular surgery may not be included in this registry. Any patient with an estimated life expectancy less than the first follow-up period, i.e. 12 months is excluded from data entry. Any patient with a known and documented allergy to silver or silver ions.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with PAOD or aneurysms<br>Patients in Fontaine class > IIa, in need of aneurysm repair, with defined cardiovascular risk factors or graft infections. Surgical reconstruction with defined Silver Graft vascular prosthesis. | Procedure: Surgical reconstruction<br>* 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.<br>* Other names: Silver Graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| graft patency | 12-month patency assessed with duplex ultrasound | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from infection | assessed through clinical parameters, imaging (ultrasound, MRI, CT), bacterial cultures | at 12 months |