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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01710878
Other study ID # HR07-001
Secondary ID
Status Completed
Phase N/A
First received October 10, 2012
Last updated November 24, 2013
Start date February 2008
Est. completion date December 2012

Study information

Verified date November 2013
Source Maquet Cardiovascular
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.


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.


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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Intergard Synergy Graft


Locations

Country Name City State
France CHRU Angers
France CHU Jean Minjoz Besançon
France CHU Dupuytren Limoges
France Hôpital Edouard Herriot Lyon
France Hôpital G. et R. Laennec Nantes
France Hôpital Pompidou Paris
France CHU La Milétrie Poitiers
Germany Krankenhaus Nordwest Frankfurt

Sponsors (1)

Lead Sponsor Collaborator
Maquet Cardiovascular

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Secondary endpoint - levels of silver and triclosan Serum levels prior to surgery, 1 day post-implant, discharge and 30 days Up to 30 days Yes
Primary Primary Graft Patency Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months Up to 36 months No
Secondary Secondary endpoint - assessment of AEs Follow-up timeframes - 1, 6, 12, 24, and 36 months Up to 36 months Yes
See also
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