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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01970605
Other study ID # AAG-O-H-1310
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2013
Est. completion date December 2018

Study information

Verified date January 2019
Source B. Braun Melsungen AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 230
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgical 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.

Locations

Country Name City State
Germany Klinikum Magdeburg Magdeburg

Sponsors (1)

Lead Sponsor Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Freedom from perigraft fluid presence assessed through imaging (ultrasound, MRI, CT) 12 months
Primary graft patency 12-month patency assessed with duplex ultrasound 12 months
Secondary Freedom from infection assessed through clinical parameters, imaging (ultrasound, MRI, CT), bacterial cultures at 12 months
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