InterGard Synergy Post-Marketing Surveillance Study
|ClinicalTrials.gov Identifier: NCT01698671|
Recruitment Status : Unknown
Verified November 2013 by Maquet Cardiovascular.
Recruitment status was: Active, not recruiting
First Posted : October 3, 2012
Last Update Posted : November 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Aortic Aneurysm, Abdominal Occlusive Disease of Artery of Lower Extremity||Device: InterGard Synergy Vascular Graft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||InterGard Synergy Post-Marketing Surveillance Study|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||May 2014|
|InterGard Synergy Vascular Graft||Device: InterGard Synergy Vascular Graft|
- Graft Patency and Complications [ Time Frame: 6 months ]
- 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 ]Mortality rate will be assessed up to 6 months post implantation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698671
|Graz, Vienna, Austria|
|Frankfurt, Karlsruhe, Germany|
|Heidelberg, Hamburg, Hanau, Germany|
|Principal Investigator:||Max Zegelman, MD||Krankenhaus Nordwest|