Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position

Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in Abdominal Position

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01710878

Acronym

SYNERGY

Enrollment

Registered

2012-10-19

Start date

2008-02-29

Completion date

2012-12-31

Last updated

2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aorta Aneurysm

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.

Interventions

DEVICEIntergard Synergy Graft

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Graft Patency	Up to 36 months	Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months

Secondary

Measure	Time frame	Description
Secondary endpoint - assessment of AEs	Up to 36 months	Follow-up timeframes - 1, 6, 12, 24, and 36 months

Other

Measure	Time frame	Description
Secondary endpoint - levels of silver and triclosan	Up to 30 days	Serum levels prior to surgery, 1 day post-implant, discharge and 30 days

Countries

France, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026