Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-06 @ 12:52 AM
Study NCT ID:
NCT01970605
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Silver Graft All Comers Registry
Sponsor:
B. Braun Melsungen AG
Organization:
Study Overview
Official Title:
Silver Graft All Comers Registry is to Assess the Long Term Clinical Benefit of Silver Graft in an Unselected Patient Population
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: