Silver Graft All Comers Registry

B. Braun

Status: Completed

Conditions: Graft Failure; Aneurysm; Graft Infection

Treatments: Procedure: Surgical reconstruction

Study type: Observational

Funder types: Industry

Identifiers

NCT01970605

AAG-O-H-1310

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

230 participants in 1 patient group

Patients with PAOD or aneurysms

Description:

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.

Treatment:

Procedure: Surgical reconstruction