Silver Graft All Comers Registry

Completed

• Conditions: Aneurysm; Graft Infection; Graft Failure
• Interventions: Procedure: Surgical reconstruction

• Registration Number: NCT01970605
• Lead Sponsor: B. Braun Melsungen AG

Brief 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

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-28
• Primary Completion: 2017-12
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PAOD or aneurysms	Surgical reconstruction	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.

Primary Outcome Measures

Name	Time	Method
graft patency	12 months	12-month patency assessed with duplex ultrasound

Secondary Outcome Measures

Name	Time	Method
Freedom from infection	at 12 months	assessed through clinical parameters, imaging (ultrasound, MRI, CT), bacterial cultures

Trial Locations

Locations (1)

Klinikum Magdeburg; 🇩🇪 Magdeburg, Germany