TriVascular European Union (EU) Abdominal Stent Graft Trial
|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: NCT01097772|
Recruitment Status : Completed
First Posted : April 2, 2010
Last Update Posted : November 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Device: Implant of Ovation Abdominal Stent Graft System||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation™ Abdominal Stent Graft System|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||October 2015|
Ovation Abdominal Stent Graft System
Implant of Ovation Abdominal Stent Graft System
Device: Implant of Ovation Abdominal Stent Graft System
Single occurrence permanent implant of AAA device.
- The primary safety endpoint is defined as the proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure. [ Time Frame: 30-Days ]The safety of the TriVascular AAA Stent Graft will be determined by comparing the rate of Serious Adverse Events in the Treatment Group against the rate of Serious Adverse Events in the Control Group within 30 days of the initial procedure.
- To evaluate the performance of the TriVascular AAA Stent-Graft System within 30 days of the initial procedure. [ Time Frame: 30-Days ]
The performance of the TriVascular AAA Stent-Graft System will be determined by comparing the composite success rate in the Treatment Group against an estimated success rate of 80% in the Control Group within 30 days of the initial procedure. The composite success rate is defined as:
- Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs.
- Absence of Type I and III endoleaks
- Absence of Rupture
- Absence of Conversion to Open Surgical Repair
- Freedom from mortality
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): NCT01097772
|Herz- und Gefässzentrum Bad Bevensen|
|Bad Bevensen, Germany, 29549|
|Principal Investigator:||Thomas Nolte, MD||Herz- und Gefässzentrum Bad Bevensen|