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.
Inclusion Criteria: 1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair. 2. Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device. Exclusion Criteria: 1. Do not comply with the indications for Aorfix™ in the IFU. 2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care of the investigative site. 3. Unwillingness or inability to provide informed consent to both the study and the EVAR procedure. 4. 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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