The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system for endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac aneurysms.
The Endurant Evo International Clinical Trial is a prospective, multi-center, premarket, non-randomized, single-arm trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Krankenhaus Hietzing
Vienna, Austria
Wilhelminenspital
Vienna, Austria
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium
Primary Safety Endpoint Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation.
MAEs include the occurrence of any of the following events: All-cause mortality Bowel ischemia Myocardial infarction Paraplegia Procedural blood loss ≥1000 cc Renal failure Respiratory failure Stroke
Time frame: 30 days
Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure.
Technical success at the index procedure (as assessed intra-operatively up until closure of the access site), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system
Time frame: Index procedure
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
All-cause-mortality within 30, 183, and 365 days and annually until 5 years.
Time frame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
Aneurysm-related mortality within 30, 183, and 365 days, then annually until 5-Year post-implantation
Time frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
Secondary procedures to correct Type I and III endoleaks within 183 and 365 day, then annually until 5-Year post-implantation
Time frame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Odense Universitetshospital
Odense, Denmark
Rijnstate - Locatie Arnhem
Arnhem, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Skånes Universitetssjukhus Malmö
Malmö, Sweden
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
Secondary endovascular procedures within 30, 183, and 365 days, then annually until 5-Year post-implantation.
Time frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Serious Adverse Events (SAE)
Serious adverse events within 30, 183, and 365 days, then annually until 5-Year post-implantation
Time frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Aneurysm Rupture
Aneurysm rupture within 30, 183, and 365 days, then annually until 5-Year post-implantation
Time frame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Conversion to Ppen Surgery
Conversion to open surgery within 30, 183, and 365 days, then annually until 5-Year post-implantation
Time frame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Major Adverse Events (MAE)
Major adverse events within 183, and 365 days, then annually until 5-Year post-implantation
Time frame: Within 183, and 365 days, then annually until 5-Year post-implantation
the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)
Stent graft migration (as compared to 1-month imaging) through 12-month, 24-month, 36-month, 48-month and 60-month using worst case.
Time frame: Through 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)
Aneurysm expansion \> 5 mm (as compared to 1-month imaging) at 12-month, 24-month, 36-month, 48-month and 60-month
Time frame: 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subject With Endoleaks Based on Imaging Findings
Table will show a total number of subjects with endoleak at each follow up time point
Time frame: 1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subjects With Stent Graft Occlusion Based on Imaging Findings
Stent graft occlusion based on imaging findings through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Time frame: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subject With Device Deficiencies Based on Imaging Findings
Total number of subject with Any Device Deficiency through the follow up time points.
Time frame: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month