ClinicalTrials.gg
Sign In
CompletedNCT01970605Updated Jan 23, 2019

Silver Graft All Comers Registry

An observational study in Aneurysm, Graft Failure and Graft Infection, sponsored by B. Braun Melsungen AG. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2019-01-23.

Sponsored by B. Braun Melsungen AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
230
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Aneurysm
  • Graft Failure
  • Graft Infection

Browse trials for

03

In context

Aneurysm

956 studies on the registry are indexed under Aneurysm; 171 are open to participants now.

This study's enrollment of 230 is above the median of 150 across 441 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

B. Braun Melsungen AG is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Browse B. Braun studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
230 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with PAOD or aneurysms

    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.

    Procedure: Surgical 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.

    Also known as: Vascular reconstruction, Vascular prosthesis, Silver Graft

06

What researchers measure

Primary outcomes

  1. graft patency

    12-month patency assessed with duplex ultrasound

    Time frame: 12 months

Secondary outcomes

  1. Freedom from infection

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

    Time frame: at 12 months

Other outcomes

  1. Freedom from perigraft fluid presence

    assessed through imaging (ultrasound, MRI, CT)

    Time frame: 12 months

07

Study locations

1 site
  • Klinikum Magdeburg
    Magdeburg, 39130, Germany
08

References and documents

Publications

  • 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. PubMed 23508393 ↗
  • 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. PubMed 19698298 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2013, a primary completion of Dec 2017 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2013
First posted
Oct 28, 2013
Start
Oct 2013
Primary completionActual
Dec 2017
CompletionActual
Dec 2018
Last update
Jan 23, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01970605
Lead sponsor
B. Braun Melsungen AG
Responsible party
Sponsor
First posted
Oct 28, 2013
Start date
Oct 2013
Primary completion
Dec 2017
Completion
Dec 2018
Last update
Jan 23, 2019

Study contacts

Jörg Tautenhahn, MD
principal investigator · Klinikum Magdeburg

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Aneurysm →

Other studies from this sponsor

B. Braun Melsungen AG →

Start the discussion