TriVascular Post-Market Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01372709|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2011
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment|
|Abdominal Aortic Aneurysm||Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System|
|Study Type :||Observational|
|Actual Enrollment :||501 participants|
|Official Title:||A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System|
|Study Start Date :||May 2011|
|Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||January 2019|
Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Adult male and female patients will be consecutively screened for the study. Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria.
Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Single occurrence permanent implant of AAA device.
- Treatment Success at 12 Months Post-Implantation/surgery. [ Time Frame: 12 Months ]The primary endpoint is treatment success at 12 months post-implantation/surgery. Treatment success is defined as a composite technical endpoint composed of successful introduction and deployment of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System at the initial implantation procedure along with clinical endpoints of absence from type I or III endoleaks, aneurysm expansion, aneurysm rupture, conversion to open surgical repair, graft migration, and graft occlusion at 12 months post-implantation procedure.
- Safety and Performance Endpoints [ Time Frame: 1, 6, &12 Months ]
- Freedom from type I and III endoleaks [1 & 6 m, & annual through 5 years]
- Freedom from aneurysm rupture [6 m, & annual through 5 years]
- Freedom from aneurysm related mortality [1 month]
- Freedom from aneurysm expansion [6 m, & annual through 5 years]
- Freedom from stent graft migration [6 m, & annual through 5 years]
- Freedom from loss of device patency [1 & 6 m, & annual through 5 years]
- Freedom from aneurysm-related secondary endovascular procedures [1 & 6 m, & annual through 5 years]
- Freedom from device related adverse events [1 & 6 m, & annual through 5 years]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372709
|Park Hospital Leipzig|
|Strümpellstr. 41, Leipzig, Germany, 04289|