Aneurysm, Graft Failure, Graft Infection
Conditions
Brief summary
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
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: 1. Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair. or 2. 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 3. Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.
Interventions
PROCEDURESurgical reconstruction
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.
Sponsors
B. Braun Melsungen AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair. 2. 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 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| graft patency | 12 months | 12-month patency assessed with duplex ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from infection | at 12 months | assessed through clinical parameters, imaging (ultrasound, MRI, CT), bacterial cultures |
Other
| Measure | Time frame | Description |
|---|---|---|
| Freedom from perigraft fluid presence | 12 months | assessed through imaging (ultrasound, MRI, CT) |
Countries
Germany
Outcome results
None listed