Silver Graft All Comers Registry

Aneurysm Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Aneurysm
• Graft Failure
• Graft Infection

• NCT number: NCT01970605
• Study type: Observational
• Source: B. Braun Melsungen AG
• Status: Completed
• Start date: October 2013
• Completion date: December 2018