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Completed

NCT Number: NCT01970605

Silver Graft All Comers Registry

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

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Key information

Conditions

Aneurysm Cardiovascular Diseases Graft Failure Graft Infection Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Magdeburg

Magdeburg, 39130, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical reconstruction

Procedure

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.

Other names: Vascular reconstruction, Vascular prosthesis, Silver Graft

Primary outcomes

  1. graft patency

    Time frame: 12 months

    12-month patency assessed with duplex ultrasound

Secondary outcomes

  1. Freedom from infection

    Time frame: at 12 months

    assessed through clinical parameters, imaging (ultrasound, MRI, CT), bacterial cultures

Other outcomes

  1. Freedom from perigraft fluid presence

    Time frame: 12 months

    assessed through imaging (ultrasound, MRI, CT)

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Oct 28, 2013
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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