AneurysmNCT01970605

Silver Graft All Comers Registry

An observational study of Aneurysm and Graft Failure, run by B. Braun Melsungen AG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 Read more about this study

Who is it for?: Any age
Conditions the study is for: Aneurysm, Graft Failure, Graft Infection
What is being tested?: Surgical reconstruction
Type of treatment: Surgery or procedure
How many people: 230 participants
Where: 1 siteGermany
Study dates: Oct 2013to Dec 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with PAOD Fontaine classification > IIa Patients in need of aneurysm repair Patients in need of revisions, i.e. graft infections

Who may be able to join

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)

Show all 11Show fewer

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Germany1 site

Klinikum Magdeburg
Magdeburg, 39130

Other trials in Germany

About this study

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

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:

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.

Conditions: Aneurysm, Graft Failure, Graft Infection
Being tested: Surgical reconstruction
Medical subject headings: Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Surgical reconstructionProcedure or surgery
Also called Vascular reconstruction, Vascular prosthesis, Silver Graft
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.

Study groups in NCT01970605
Study group	Role	What they receive
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. Receives: Procedure: Surgical reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

graft patency
12-month patency assessed with duplex ultrasound
Measured: 12 months

Secondary outcomes (1)

Freedom from infection
assessed through clinical parameters, imaging (ultrasound, MRI, CT), bacterial cultures
Measured: at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Dec 2018

First posted28 Oct 2013 (estimated)
Study startOct 2013
Primary completionDec 2017
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AneurysmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01970605
Sponsor's protocol ID: AAG-O-H-1310
Status last verified: Jan 2019
First submitted: 23 Oct 2013
Last updated: 23 Jan 2019
Results posted: No
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Silver Graft All Comers Registry is to Assess the Long Term Clinical Benefit of Silver Graft in an Unselected Patient Population
ClinicalTrials.gov ID: NCT01970605
Acronym / sponsor ID: AAG-O-H-1310
Conditions: Aneurysm, Graft Failure, Graft Infection
Study type: Observational
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: B. Braun Melsungen AGIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Dec 2017 (actual)
Study completion: Dec 2018 (actual)
First posted: 28 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with PAOD or aneurysms	–	Procedure: Surgical reconstructionPatients * 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with PAOD Fontaine classification > IIa Patients in need of aneurysm repair Patients in need of revisions, i.e. graft infections

Key inclusion criteria (11 listed)

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
Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Surgical reconstructionAlso: Vascular reconstruction, Vascular prosthesis, Silver GraftIn 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.	Procedure or surgery	Patients with PAOD or aneurysms

Primary outcome

graft patency
Time frame: 12 months
12-month patency assessed with duplex ultrasound

1 secondary outcome

Freedom from infection
Time frame: at 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
Background: PubMed 23508393Zegelman 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.
Background: PubMed 19698298Zegelman 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jörg Tautenhahn, MD principal investigator

Klinikum Magdeburg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Aneurysm and Graft Failure, run by B. Braun Melsungen AG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

graft patency (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01970605, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.