Clinical trial NCT01970605: Silver Graft All Comers Registry
Official title: Silver Graft All Comers Registry is to Assess the Long Term Clinical Benefit of Silver Graft in an Unselected Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm
Graft Failure
Graft Infection
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with PAOD Fontaine classification \> IIa Patients in need of aneurysm repair Patients in need of revisions, i.e. graft infections

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.

Eligibility criteria: 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.

Primary outcomes:
measure: graft patency
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from infection
timeFrame: at 12 months
Other outcomes:
measure: Freedom from perigraft fluid presence
timeFrame: 12 months
Locations:
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg
Study officials:
affiliation: Klinikum Magdeburg
name: Jörg Tautenhahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.