|
General |
Study Status |
Other |
Application Number / Requirement Number |
P110032 / PAS002 |
Date Original Protocol Accepted |
06/06/2014
|
Date Current Protocol Accepted |
 
|
Study Name |
Comprehensive/Linked-Registry Based Surv
|
Device Name |
AORFIX FLEXIBLE STENT GRAFT SYSTEM
|
General Study Protocol Parameters |
Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
Data Source |
External Registry
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Detailed Study Protocol Parameters |
Study Objectives |
Surveillance of Aorfix patients entered into the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI)
|
Study Population |
Patients implanted with the Aorfix for its intended use
|
Sample Size |
234 prospectively enrolled patients
|
Key Study Endpoints |
Procedural information, including the number of devices used, procedural duration, blood loss, and postoperative leg or bowel ischemia. The surveillance should also monitor aneurysm-related mortality, device migration, fracture in the fixation zone, conversion to open surgery, change in aneurysm size, aneurysm rupture, graft patency, secondary interventions, change in renal function, and endoleaks (including Type)
|
Follow-up Visits and Length of Follow-up |
5 years
|
Interim or Final Data Summary |
Interim Results |
Clinically assessed patency at 3 and 4 years was 100% (24/24 and 15/15, respectively) for the main body and limbs. No device migration or fracture was observed. 7 patients demonstrated sac expansion by volume.
|
Actual Number of Patients Enrolled |
42
|
Actual Number of Sites Enrolled |
17
|
Patient Follow-up Rate |
36/36 (100%) clinical follow-up and 11/35 (11%) CT follow-up at 3 years 24/33 (73%) clinical follow-up and 6/33 (18%) CT follow-up at 4 years
|
Study Strengths & Weaknesses |
The device is no longer marketed in the U.S. The study is on hold and there is no continued enrollment. Enrollment is low and CT follow-up is limited, making it difficult to interpret results from minimal data. Patency is appropriate and no device migration or fracture was observed.
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