Aorfix Intelliflex First in Human Study
This trial is active, not recruiting.
|Condition||aortic aneurysm, abdominal|
|Treatment||endovascular aneurysm repair evar|
|Start date||November 2015|
|End date||November 2017|
|Trial size||10 participants|
|Trial identifier||NCT02907762, 2015-07|
The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.
Number of participants with Successful Implant Delivery (30d) and Treatment Success (1year)
time frame: 12 Months
Male or female participants at least 21 years old.
- Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
- Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.
- Do not comply with the indications for Aorfix™ in the IFU.
- Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care of the investigative site.
- Unwillingness or inability to provide informed consent to both the study and the EVAR procedure.
- Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.
|Official title||Aorfix™ Generation IV Delivery System "IntelliFlex™" Study|
|Principal investigator||Andrew Holden, MD|
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