Silver Graft All Comers Registry

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

Study Overview

• Status: Completed
• Conditions: Aneurysm; Graft Failure; Graft Infection
• Intervention / Treatment: Procedure: Surgical reconstruction

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.

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Germany
  • Magdeburg, Germany, 39130
    • Klinikum Magdeburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
graft patency	12-month patency assessed with duplex ultrasound	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from infection	assessed through clinical parameters, imaging (ultrasound, MRI, CT), bacterial cultures	at 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from perigraft fluid presence	assessed through imaging (ultrasound, MRI, CT)	12 months

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Jörg Tautenhahn, MD, Klinikum Magdeburg

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 28, 2013

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: AAG-O-H-1310