AAA, Abdominal Aortic Aneurysm
Conditions
Brief summary
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.
Detailed description
The Endurant Evo International Clinical Trial is a prospective, multi-center, premarket, non-randomized, single-arm trial.
Interventions
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years old 2. Subject understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board. 3. Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements 4. Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III 5. Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more of the following: * Aneurysm is \> 5 cm in diameter (diameter measured is perpendicular to the line of flow) * Aneurysm is 4 - 5 cm in diameter and has increased in size ≥ 0.5 cm within the previous 6 months 6. Subject meets all the following anatomical criteria as demonstrated on contrast-enhanced CT or Magnetic Resonance Angiography (MRA) imaging: * Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° suprarenal neck angulation or Proximal neck length of ≥ 15 mm with ≤ 75° infrarenal and ≤ 60° suprarenal neck angulation * Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for the Endurant Evo AAA stent graft system (measured intima to intima) and within the sizing recommendations (refer to Endurant Evo AAA stent graft system Instructions for Use (IFU)) * Subject has a proximal aortic neck diameter ≥18 mm and ≤32 mm * The distal fixation center of the iliac arteries must have a diameter ≥7 mm and ≤ 25 mm bilaterally for the bifurcation and unilaterally for the Aorto-Uni-Iliac (AUI) * Subject has documented imaging evidence of at least one patent iliac and one femoral artery, or can tolerate a vascular conduit that allows introduction of the Endurant Evo AAA stent graft system * Subject has distal non-aneurysmal iliac (cylindrical) fixation length ≥ 20 mm bilaterally for the bifurcation and unilaterally for the AUI
Exclusion criteria
1. Subject has a life expectancy ≤ 1 year 2. Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study 3. Subject is pregnant 4. Subject has an aneurysm that is: * Suprarenal/ pararenal/ juxtarenal * Isolated ilio-femoral * Mycotic * Inflammatory * Pseudoaneurysm * Dissecting * Ruptured * Leaking but not ruptured 5. Subject requires emergent aneurysm treatment 6. Subject has a known, untreated thoracic aneurysm \>4.5 cm in diameter at time of screening 7. Subject has been previously treated for an abdominal aortic aneurysm 8. Subject has a history of bleeding diathesis or coagulopathy 9. Subject has had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the Endurant Evo AAA stent graft 10. Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to implantation of the Endurant Evo AAA stent graft 11. Subject has a conical neck defined as a \>4 mm distal increase from the lowest renal artery over a 10 mm length 12. Subject has a known allergy or intolerance to the device materials 13. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment 14. Subject has significant aortic thrombus and/or calcification at either the proximal or distal attachment centers that would compromise fixation and seal of the device at the discretion of the investigator 15. Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow 16. Subject whose arterial access site is not anticipated to accommodate the diameter of the Endurant Evo AAA delivery system (13F-17F) due to vessel size, calcification, or tortuosity 17. Subject is morbidly obese or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta at the discretion of the investigator 18. Subject has active infection at the time of the index procedure documented by e.g. pain, fever, drainage, positive culture and/or leukocytosis considered to be clinically significant per investigator discretion 19. Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome 20. Subject has a creatinine level \>2.00 mg/dl (or \>176.8 µmol/L) 21. Subject is on dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation. | 30 days | 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 |
| Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point | Within 30, 183, and 365 days, then annually until 5-Year post-implantation | Secondary procedures to correct Type I and III endoleaks within 183 and 365 day, then annually until 5-Year post-implantation |
| Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point | within 30, 183, and 365 days, then annually until 5-Year post-implantation | Secondary endovascular procedures within 30, 183, and 365 days, then annually until 5-Year post-implantation. |
| Number of Subjects With Serious Adverse Events (SAE) | within 30, 183, and 365 days, then annually until 5-Year post-implantation | Serious adverse events within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| The Number of Subjects With Aneurysm Rupture | Within 30, 183, and 365 days, then annually until 5-Year post-implantation | Aneurysm rupture within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| The Number of Subjects With Conversion to Ppen Surgery | Within 30, 183, and 365 days, then annually until 5-Year post-implantation | Conversion to open surgery within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| Number of Subjects With All-Cause Mortality (ACM) at Each Follow up | Within 30, 183, and 365 days, then annually until 5-Year post-implantation | All-cause-mortality within 30, 183, and 365 days and annually until 5 years. |
| the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging) | Through 12-month, 24-month, 36-month, 48-month and 60-month | Stent graft migration (as compared to 1-month imaging) through 12-month, 24-month, 36-month, 48-month and 60-month using worst case. |
| Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging) | 12-month, 24-month, 36-month, 48-month and 60-month | Aneurysm expansion \> 5 mm (as compared to 1-month imaging) at 12-month, 24-month, 36-month, 48-month and 60-month |
| Number of Subject With Endoleaks Based on Imaging Findings | 1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month | Table will show a total number of subjects with endoleak at each follow up time point |
| Number of Subjects With Stent Graft Occlusion Based on Imaging Findings | Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month | Stent graft occlusion based on imaging findings through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month |
| Number of Subject With Device Deficiencies Based on Imaging Findings | Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month | Total number of subject with Any Device Deficiency through the follow up time points. |
| The Number of Subjects With Major Adverse Events (MAE) | Within 183, and 365 days, then annually until 5-Year post-implantation | Major adverse events within 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 | within 30, 183, and 365 days, then annually until 5-Year post-implantation | Aneurysm-related mortality within 30, 183, and 365 days, then annually until 5-Year post-implantation |
Countries
Austria, Belgium, Denmark, Netherlands, Sweden
Participant flow
Recruitment details
Patients were screened for enrollment based on the study Inclusion/Exclusion criteria between Jun 2015 and Mar 2016.
Participants by arm
| Arm | Count |
|---|---|
| Abdominal Aortic Aneurysm Endovasculair Repair Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria. | 69 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 16 |
| Overall Study | Device Explanted | 5 |
| Overall Study | Missed Visit | 6 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Abdominal Aortic Aneurysm Endovasculair Repair | — |
|---|---|---|
| Age, Continuous | 71.8 Years STANDARD_DEVIATION 6.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 5 participants | — |
| Region of Enrollment Belgium | 11 participants | — |
| Region of Enrollment Denmark | 10 participants | — |
| Region of Enrollment Netherlands | 34 participants | — |
| Region of Enrollment Sweden | 9 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 61 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 69 |
| other Total, other adverse events | 6 / 69 |
| serious Total, serious adverse events | 54 / 69 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure. | 69 Participants |
Comparison: The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG.p-value: 0.001Based on exact binomial distribution
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Primary Safety Endpoint Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation. | 2 Participants |
Comparison: The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a Major Adverse Event (MAE) within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system and 20% is the safety PG.p-value: <0.001Exact binomial test
Secondary
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
Population: Within 0-365 days, 69 subjects were evaluable. Within 366-731 days, 66 subject were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 days, 50 subjects were evaluable. Within 1462-1826 days, 46 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With All-Cause Mortality (ACM) at Each Follow up | All-cause-mortality (ACM) 1097-1461 Days | 1 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With All-Cause Mortality (ACM) at Each Follow up | All-cause-mortality (ACM) 1462-1826 | 3 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With All-Cause Mortality (ACM) at Each Follow up | All-cause-mortality (ACM) 0-30 Days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With All-Cause Mortality (ACM) at Each Follow up | All-cause-mortality (ACM) 0-183 Days | 2 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With All-Cause Mortality (ACM) at Each Follow up | All-cause-mortality (ACM) 0-365 Days | 3 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With All-Cause Mortality (ACM) at Each Follow up | All-cause-mortality (ACM) 366-731 Days | 3 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With All-Cause Mortality (ACM) at Each Follow up | All-cause-mortality (ACM) 732-1096 Days | 6 Participants |
Secondary
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
Population: At 12 Months, 62 subjects were evaluable. At 24 Months, 57 subjects were evaluable. At 36 Months, 43 subjects were evaluable. At 48 Months, 37 subjects were evaluable. At 60 Months, 31 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging) | Aneurysm Expansion at 12 Months | 1 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging) | Aneurysm Expansion at 24 Months | 4 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging) | Aneurysm Expansion at 36 Months | 6 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging) | Aneurysm Expansion at 48 Months | 5 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging) | Aneurysm Expansion at 60 Months | 2 Participants |
Secondary
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
Population: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 days, 50 subjects were evaluable. Within 1462-1826 days, 46 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point | Aneurysm-related mortality (ARM) 0-30 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point | Aneurysm-related mortality (ARM) 0-183 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point | Aneurysm-related mortality (ARM) 0-365 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point | Aneurysm-related mortality (ARM) 366-731 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point | Aneurysm-related mortality (ARM) 732-1096 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point | Aneurysm-related mortality (ARM) 1097-1461 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point | Aneurysm-related mortality (ARM) 1462-1826 days | 0 Participants |
Secondary
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
Population: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 67 subjects were evaluable. Within 366-731 days, 65 subjects were evaluable. Within 732-1096 days, 57 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable.\* Within 1462-1826 days, 46 subjects were evaluable.\*~\*Reporting of events between 3 -5 years follow-up were only required when related to the device, procedure, aneurysm, or subject death
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point | Secondary Endovascular procedure 0-30 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point | Secondary Endovascular procedure 0-183 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point | Secondary Endovascular procedure 0-365 days | 2 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point | Secondary Endovascular procedure 366-731 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point | Secondary Endovascular procedure 732-1096 days | 4 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point | Secondary Endovascular procedure 1097- 1461 days | 7 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point | Secondary Endovascular procedure 1462-1826 days | 3 Participants |
Secondary
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
Population: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 65 subjects were evaluable. Within 732-1096 days, 57 subjects were evaluable. Note: Reporting of secondary endovascular procedures between 3 and 5 years of follow-up were only required when corresponding to adverse events related to the device, procedure, aneurysm, or subject death.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point | 0-30 Days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point | 0-183 Days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point | 0-365 Days | 1 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point | 366-731 Days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point | 732-1096 Days | 1 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point | 1097-1461 Days | 3 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point | 1462-1826 Days | 1 Participants |
Secondary
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
Population: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 69 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable.\* Within 1462-1826 days, 46 subjects were evaluable.\*~\*Reporting of events between 3 -5 years follow-up were only required when related to the device, procedure, aneurysm, or subject death
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Serious Adverse Events (SAE) | Serious Adverse Events (SAE) 0-30 Days | 9 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Serious Adverse Events (SAE) | Serious Adverse Events (SAE) 0-183 Days | 19 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Serious Adverse Events (SAE) | Serious Adverse Events (SAE) 0-365 Days | 25 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Serious Adverse Events (SAE) | Serious Adverse Events (SAE) 366-731 Days | 18 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Serious Adverse Events (SAE) | Serious Adverse Events (SAE) 732- 1096 Days | 19 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Serious Adverse Events (SAE) | Serious Adverse Events (SAE) 1097-1461 Days | 12 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Serious Adverse Events (SAE) | Serious Adverse Events (SAE) 1462-1826 Days | 8 Participants |
Secondary
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
Population: Through 6 Months, 61 subjects were evaluable. Through 12 Months, 60 subjects were evaluable. Through 24 Months, 55 subjects were evaluable. Through 36 Months, 40 subjects were evaluable. Through 48 Months, 34 subjects were evaluable. Through 60 Months, 30 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Stent Graft Occlusion Based on Imaging Findings | Stent Graft Occlusion through 6 months | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Stent Graft Occlusion Based on Imaging Findings | Stent Graft Occlusion through 12 months | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Stent Graft Occlusion Based on Imaging Findings | Stent Graft Occlusion through 24 months | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Stent Graft Occlusion Based on Imaging Findings | Stent Graft Occlusion through 36 months | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Stent Graft Occlusion Based on Imaging Findings | Stent Graft Occlusion through 48 months | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subjects With Stent Graft Occlusion Based on Imaging Findings | Stent Graft Occlusion through 60 months | 0 Participants |
Secondary
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
Population: Through 6 Months, 61 subjects were evaluable. Through 12 Months, 65 subjects were evaluable. Through 24 Months, 61 subjects were evaluable. Through 36 Months, 57 subjects were evaluable. Through 48 Months, 55 subjects were evaluable. Through 60 Months, 51 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Device Deficiencies Based on Imaging Findings | Any device deficiency through 6 months | 15 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Device Deficiencies Based on Imaging Findings | Any device deficiency through 12 months | 25 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Device Deficiencies Based on Imaging Findings | Any device deficiency through 24 months | 33 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Device Deficiencies Based on Imaging Findings | Any device deficiency through 36 months | 35 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Device Deficiencies Based on Imaging Findings | Any device deficiency through 48 months | 36 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Device Deficiencies Based on Imaging Findings | Any device deficiency through 60 months | 36 Participants |
Secondary
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
Population: At 1 Month, 66 subjects were evaluable. At 6 Months, 60 subjects were evaluable. At 12 Months, 58 subjects were evaluable. At 24 Months, 54 subjects were evaluable. At 36 Months, 40 subjects were evaluable. At 48 Months, 35 subjects were evaluable. At 60 Months, 30 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Endoleaks Based on Imaging Findings | Participants with any type of endoleak at 12 Months | 14 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Endoleaks Based on Imaging Findings | Participants with any type of endoleak at 1 Month | 25 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Endoleaks Based on Imaging Findings | Participants with any type of endoleak at 6 Months | 16 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Endoleaks Based on Imaging Findings | Participants with any type of endoleak at 24 Months | 9 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Endoleaks Based on Imaging Findings | Participants with any type of endoleak at 36 Months | 8 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Endoleaks Based on Imaging Findings | Participants with any type of endoleak at 48 Months | 6 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | Number of Subject With Endoleaks Based on Imaging Findings | Participants with any type of endoleak at 60 Months | 2 Participants |
Secondary
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
Population: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 49 subjects were evaluable. Within 1462-1826 days, 45 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Aneurysm Rupture | Aneurysm Rupture 0732-1096 days | 1 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Aneurysm Rupture | Aneurysm Rupture 366-731 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Aneurysm Rupture | Aneurysm Rupture 0-30 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Aneurysm Rupture | Aneurysm Rupture 0-183 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Aneurysm Rupture | Aneurysm Rupture 0-365 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Aneurysm Rupture | Aneurysm Rupture 1097-1461 days | 1 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Aneurysm Rupture | Aneurysm Rupture 1462-1826 days | 0 Participants |
Secondary
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
Population: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable. Within 1462-1826 days, 45 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Conversion to Ppen Surgery | Conversion to open surgery 0-30 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Conversion to Ppen Surgery | Conversion to open surgery 0-183 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Conversion to Ppen Surgery | Conversion to open surgery 0-365 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Conversion to Ppen Surgery | Conversion to open surgery 365-731 days | 3 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Conversion to Ppen Surgery | Conversion to open surgery 732-1096 days | 0 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Conversion to Ppen Surgery | Conversion to open surgery 1097-1461 days | 2 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Conversion to Ppen Surgery | Conversion to open surgery 1462-1826 days | 0 Participants |
Secondary
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
Population: Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 69 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable. Within 1462-1826 days, 45 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Major Adverse Events (MAE) | Major Adverse Events (MAEs) 0-183 days | 5 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Major Adverse Events (MAE) | Major Adverse Events (MAEs) 0-365 days | 6 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Major Adverse Events (MAE) | Major Adverse Events (MAEs) 366-731 days | 6 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Major Adverse Events (MAE) | Major Adverse Events (MAEs) 732-1096 days | 6 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Major Adverse Events (MAE) | Major Adverse Events (MAEs) 1097-1461 days | 7 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | The Number of Subjects With Major Adverse Events (MAE) | Major Adverse Events (MAEs) 1462-1826 days | 5 Participants |
Secondary
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
Population: Through 12 Months, 61 subjects were evaluable. Through 24 Months, 56 subjects were evaluable. Through 36 Months, 45 subjects were evaluable. Through 48 Months, 37 subjects were evaluable. Through 60 Months, 31 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular Repair | the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging) | Stent Graft Migration through 12 Months | 1 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging) | Stent Graft Migration through 24 Months | 1 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging) | Stent Graft Migration through 36 Months | 1 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging) | Stent Graft Migration through 48 Months | 1 Participants |
| Abdominal Aortic Aneurysm Endovascular Repair | the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging) | Stent Graft Migration through 60 Months | 4 Participants |