InterGard Synergy Post-Marketing Surveillance Study
The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.
Aortic Aneurysm, Abdominal
Occlusive Disease of Artery of Lower Extremity
Device: InterGard Synergy Vascular Graft
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||InterGard Synergy Post-Marketing Surveillance Study|
- Graft Patency and Complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patency will be assessed by color-coded duplex ultrasound up to 6 months post implantation.
- Complications including the occurrence of graft infections will be assessed up to post implantation.
- Mortality rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]Mortality rate will be assessed up to 6 months post implantation.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||May 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|InterGard Synergy Vascular Graft||Device: InterGard Synergy Vascular Graft|
Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.
|Graz, Vienna, Austria|
|Frankfurt, Karlsruhe, Germany|
|Heidelberg, Hamburg, Hanau, Germany|
|Principal Investigator:||Max Zegelman, MD||Krankenhaus Nordwest|