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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970605
• Other study ID #: AAG-O-H-1310
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Aneurysm
• Graft Failure
• Graft Infection

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