Back to resultsPerformance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position (SYNERGY)
Primary Purpose
Abdominal Aorta Aneurysm
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intergard Synergy Graft
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Aorta Aneurysm
Eligibility Criteria
Inclusion Criteria:
Patient aged 18-85 years
Patient presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and eligible for a revascularization with a bifurcated graft
Exclusion Criteria:
Patient treated as an emergency
Patient included in another investigation
Patient pregnant or lactating or woman of childbearing potential
Patient with a known allergy to the material device used (collagen, triclosan, silver)
Patient with previous aorto-iliac bypass or replacement
Sites / Locations
- CHRU
- CHU Jean Minjoz
- CHU Dupuytren
- Hôpital Edouard Herriot
- Hôpital G. et R. Laennec
- Hôpital Pompidou
- CHU La Milétrie
- Krankenhaus Nordwest
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intergard Synergy Graft
Arm Description
Outcomes
Primary Outcome Measures
Primary Graft Patency
Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months
Secondary Outcome Measures
Secondary endpoint - assessment of AEs
Follow-up timeframes - 1, 6, 12, 24, and 36 months
Full Information
NCT ID
NCT01710878
First Posted
October 10, 2012
Last Updated
November 24, 2013
Sponsor
Maquet Cardiovascular
1. Study Identification
Unique Protocol Identification Number
NCT01710878
Brief Title
Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position
Acronym
SYNERGY
Official Title
Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in Abdominal Position
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maquet Cardiovascular
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.
Detailed Description
The purpose of this multi center, single arm study is to demonstrate the safety and performance of the Second Generation Anti-Microbial (InterGard Synergy) vascular graft in the treatment of aneurismal and occlusive diseases of the abdominal aorta.
The primary endpoint is the assessment of primary and secondary graft patency. The secondary endpoints were the assessment of adverse events and the assessment of triclosan and silver contents in the serum over the time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aorta Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intergard Synergy Graft
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Intergard Synergy Graft
Primary Outcome Measure Information:
Title
Primary Graft Patency
Description
Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months
Time Frame
Up to 36 months
Secondary Outcome Measure Information:
Title
Secondary endpoint - assessment of AEs
Description
Follow-up timeframes - 1, 6, 12, 24, and 36 months
Time Frame
Up to 36 months
Other Pre-specified Outcome Measures:
Title
Secondary endpoint - levels of silver and triclosan
Description
Serum levels prior to surgery, 1 day post-implant, discharge and 30 days
Time Frame
Up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged 18-85 years
Patient presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and eligible for a revascularization with a bifurcated graft
Exclusion Criteria:
Patient treated as an emergency
Patient included in another investigation
Patient pregnant or lactating or woman of childbearing potential
Patient with a known allergy to the material device used (collagen, triclosan, silver)
Patient with previous aorto-iliac bypass or replacement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste Ricco, MD
Organizational Affiliation
CHU La Milétrie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU
City
Angers
Country
France
Facility Name
CHU Jean Minjoz
City
Besançon
Country
France
Facility Name
CHU Dupuytren
City
Limoges
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
Country
France
Facility Name
Hôpital G. et R. Laennec
City
Nantes
Country
France
Facility Name
Hôpital Pompidou
City
Paris
Country
France
Facility Name
CHU La Milétrie
City
Poitiers
Country
France
Facility Name
Krankenhaus Nordwest
City
Frankfurt
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position
We'll reach out to this number within 24 hrs