Abdominal Aortic Aneurysm
Conditions
Keywords
Abdominal Aortic Aneurysm
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects with abdominal aortic aneurysms requiring endovascular repair.
Detailed description
In the US, abdominal aortic aneurysms (AAA) are found in 4-8% of older men and 0.5-1.5% of older women, resulting in 30,000-40,000 elective procedures and 1,400 peri-operative deaths. The most significant complication of AAA is an aneurysm sac rupture from which more than 15,000 patients die annually and is the 15th leading cause of death in elderly between 60 to 85 years of age . In Japan, it is estimated that approximately 14,000 endovascular aneurysm repair (EVAR) and open surgical repair cases were performed in the year 2010 . Abdominal aortic aneurysms can be treated three ways: (1) Medical management; (2) Open surgical repair; and (3) Endovascular aneurysm repair (EVAR). EVAR has emerged as an alternative treatment of AAA for most patients. It is less invasive than open repair and carries lower rates of early mortality and morbidity . It has also extended treatment options to patients who cannot undergo conventional surgical procedures due to a high operative risk. As EVAR technology evolves, it allows treatment of AAA with increasing complexity of the aortic neck and access vessels. The InCraft® AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. This stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, which assists the physician in deploying the device in a controlled, consistent, and precise manner within the aortic neck and iliac arteries. By isolating the aneurysmal sac, the system provides an alternative blood flow path to relieve pressure on the arterial vessel walls and minimize aneurysm growth and the potential for aneurysm sac rupture.
Interventions
DEVICEEndovascular AAA repair with InCraft®
Sponsors
Carelon Research
Quintiles, Inc.
Cordis US Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must meet ALL of the following inclusion criteria to be enrolled in the study: 1. Male or Female age 20 years or older; 2. Proximal aortic neck is 17-31mm in diameter; 3. Supra-renal aorta, at 20mm above the anticipated landing location, is smaller than the nominal diameter of the aortic bifurcate prosthesis to be used; 4. Infra-renal aortic neck is ≥10mm in length with supra-renal and infra-renal angulations ≤60°; 5. Subject has at least one of the following: 1. AAA size \> 5.0 cm; 2. Increase of the AAA diameter of \> 0.5 cm over the last 6 months; 6. Abdominal treatment length (lowest renal artery origin to the aortic bifurcation) ≥ 9.4cm; 7. Aortic bifurcation \>18mm in diameter; 8. Iliac landing zone ≥15mm in length; 9. Iliac landing zone 7-22mm in diameter; 10. Minimum access vessel size of ≥ 5mm; 11. Minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 128 mm; 12. Women of child bearing potential must be non-pregnant, non-lactating, and not planning to become pregnant during the course of the trial; and have a negative urine or serum pregnancy test within 7 days prior to index procedure; 13. Provide written informed consent and as applicable written HIPAA authorization (For US sites only) prior to initiation of study procedures; 14. Willing to comply with the specified follow-up evaluation schedule.
Exclusion criteria
* Subjects will be excluded if ANY of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Aneurysm Treatment | Up to 1 year post-procedure | Successful aneurysm treatment which is a composite endpoint of the following: * Technical Success at the conclusion of the index procedure, defined as successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location. The endovascular graft must be patent, with absence of types I or III endoleaks or aneurysm sac rupture, at the time of procedure completion as confirmed by angiography or other imaging modality; * Absence of post-operative aneurysm enlargement (growth \> 5 mm) or stent graft migration (\> 10mm) compared to the one month size measurement at anytime up to 1-year; * Absence of post-operative conversion to open surgery, sac rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion) at any time up to 1-year. |
| Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate | 30 days post-procedure | defined as a composite of: * Death * Stroke * Myocardial Infarction * New Onset Renal Failure (requiring dialysis) * Respiratory Failure (requires mechanical ventilation) * Paralysis/paraparesis * Bowel ischemia (requiring surgical intervention) * Procedural blood loss ≥1,000 cc |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aneurysm-related Mortality | At 30-days, 180-days, 360-days and annually to 5-years post-procedure | — |
| Incidence of Secondary Interventions | through 5 years | The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth \> 5 mm), stent graft migration (\> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture. |
| Major Adverse Events (MAEs) and Individual Components of the MAEs | At 180-days, 360-days and annually to 5-years post-procedure | — |
| Technical Success Confirmed by CT or Other Imaging Modality | At 30-days | The study evaluated technical success at 30-days as one of the secondary effectiveness endpoints. The definition of technical success is defined as patency of the endovascular graft, with the absence of Type I or III endoleaks or aneurysm sac rupture, up to 30-days post-procedure completion as confirmed by CT or other imaging modality. |
| Length of Hospital Stay (Days) Post Index Procedure | up to 17 days | — |
| Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure | up to 48 hours | — |
| Length of the Index Procedure (Minutes) | 1 day | — |
| Device-related Events | At 1 month, 6 months, 1 year and annually to 5-years post-procedure | Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft \>10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter \> 5mm compared to the 1-month measurement. |
| Procedure-related Complications | Through 1 month, 180-days, 360-days and annually to 5-years post-procedure | Adverse events that are a result of the procedure itself. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain Post-Operatively | Baseline, 1 month, 6 months and 1 year post-procedure | Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. |
| Physical Functioning Post-operatively | Screening, 1 month, 6 months and 1 year post-procedure | Physical Functioning (PF) Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. |
Countries
Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| InCraft® - AAA Stent Graft System Intervention: Endovascular AAA repair using the InCraft device
Endovascular AAA repair with InCraft® | 190 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 9 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | missed 5 year visit | 1 |
| Overall Study | Other | 53 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | InCraft® - AAA Stent Graft System |
|---|---|
| Age, Continuous Female | 75.3 years STANDARD_DEVIATION 7.47 |
| Age, Continuous Male | 73.6 years STANDARD_DEVIATION 7.58 |
| Region of Enrollment Japan | 56 participants |
| Region of Enrollment United States | 134 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 45 / 188 |
| other Total, other adverse events | 93 / 188 |
| serious Total, serious adverse events | 52 / 188 |
Outcome results
Primary
Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate
defined as a composite of: * Death * Stroke * Myocardial Infarction * New Onset Renal Failure (requiring dialysis) * Respiratory Failure (requires mechanical ventilation) * Paralysis/paraparesis * Bowel ischemia (requiring surgical intervention) * Procedural blood loss ≥1,000 cc
Time frame: 30 days post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate | 20 Participants |
p-value: 0.47Mixed Models Analysis
Primary
Number of Participants With Successful Aneurysm Treatment
Successful aneurysm treatment which is a composite endpoint of the following: * Technical Success at the conclusion of the index procedure, defined as successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location. The endovascular graft must be patent, with absence of types I or III endoleaks or aneurysm sac rupture, at the time of procedure completion as confirmed by angiography or other imaging modality; * Absence of post-operative aneurysm enlargement (growth \> 5 mm) or stent graft migration (\> 10mm) compared to the one month size measurement at anytime up to 1-year; * Absence of post-operative conversion to open surgery, sac rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion) at any time up to 1-year.
Time frame: Up to 1 year post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Number of Participants With Successful Aneurysm Treatment | 152 Participants |
Secondary
Aneurysm-related Mortality
Time frame: At 30-days, 180-days, 360-days and annually to 5-years post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Aneurysm-related Mortality | 1 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Aneurysm-related Mortality | 1 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Aneurysm-related Mortality | 1 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Aneurysm-related Mortality | 1 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Aneurysm-related Mortality | 1 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Aneurysm-related Mortality | 1 Participants |
| Site-reported Procedure-related AEs Through 5 Years | Aneurysm-related Mortality | 1 Participants |
Secondary
Device-related Events
Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft \>10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter \> 5mm compared to the 1-month measurement.
Time frame: At 1 month, 6 months, 1 year and annually to 5-years post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Device-related Events | 0 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Device-related Events | 7 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Device-related Events | 16 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Device-related Events | 24 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Device-related Events | 40 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Device-related Events | 42 Participants |
| Site-reported Procedure-related AEs Through 5 Years | Device-related Events | 48 Participants |
Secondary
Incidence of Secondary Interventions
The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth \> 5 mm), stent graft migration (\> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
Time frame: through 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Incidence of Secondary Interventions | 1 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Incidence of Secondary Interventions | 5 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Incidence of Secondary Interventions | 8 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Incidence of Secondary Interventions | 7 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Incidence of Secondary Interventions | 12 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Incidence of Secondary Interventions | 8 Participants |
| Site-reported Procedure-related AEs Through 5 Years | Incidence of Secondary Interventions | 4 Participants |
Secondary
Length of Hospital Stay (Days) Post Index Procedure
Time frame: up to 17 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InCraft® - AAA Stent Graft System | Length of Hospital Stay (Days) Post Index Procedure | 2.7 days | Standard Deviation 2.88 |
Secondary
Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure
Time frame: up to 48 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure | 8 hours |
Secondary
Length of the Index Procedure (Minutes)
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Length of the Index Procedure (Minutes) | 102.7 minutes |
Secondary
Major Adverse Events (MAEs) and Individual Components of the MAEs
Time frame: At 180-days, 360-days and annually to 5-years post-procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| InCraft® - AAA Stent Graft System | Major Adverse Events (MAEs) and Individual Components of the MAEs | Death | 3 Participants |
| InCraft® - AAA Stent Graft System | Major Adverse Events (MAEs) and Individual Components of the MAEs | Myocardial infarction | 3 Participants |
| InCraft® - AAA Stent Graft System | Major Adverse Events (MAEs) and Individual Components of the MAEs | Procedural blood loss (≥1,000 cc) | 4 Participants |
| InCraft® - AAA Stent Graft System | Major Adverse Events (MAEs) and Individual Components of the MAEs | New onset renal failure (requiring dialysis) | 0 Participants |
| InCraft® - AAA Stent Graft System | Major Adverse Events (MAEs) and Individual Components of the MAEs | Respiratory failure (requiring mechanical ventilat | 1 Participants |
| InCraft® - AAA Stent Graft System | Major Adverse Events (MAEs) and Individual Components of the MAEs | Bowel ischemia (requiring surgical intervention) | 0 Participants |
| InCraft® - AAA Stent Graft System | Major Adverse Events (MAEs) and Individual Components of the MAEs | Paralysis / paraparesis | 0 Participants |
| InCraft® - AAA Stent Graft System | Major Adverse Events (MAEs) and Individual Components of the MAEs | Stroke | 3 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Death | 6 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Respiratory failure (requiring mechanical ventilat | 2 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Paralysis / paraparesis | 0 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Stroke | 4 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Bowel ischemia (requiring surgical intervention) | 0 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Myocardial infarction | 6 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Procedural blood loss (≥1,000 cc) | 4 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | New onset renal failure (requiring dialysis) | 0 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Procedural blood loss (≥1,000 cc) | 4 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Bowel ischemia (requiring surgical intervention) | 0 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Death | 12 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Respiratory failure (requiring mechanical ventilat | 2 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Paralysis / paraparesis | 0 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Stroke | 9 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | New onset renal failure (requiring dialysis) | 0 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Major Adverse Events (MAEs) and Individual Components of the MAEs | Myocardial infarction | 7 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Bowel ischemia (requiring surgical intervention) | 0 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Procedural blood loss (≥1,000 cc) | 4 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Stroke | 13 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Myocardial infarction | 9 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | New onset renal failure (requiring dialysis) | 0 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Respiratory failure (requiring mechanical ventilat | 2 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Death | 22 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Paralysis / paraparesis | 0 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | New onset renal failure (requiring dialysis) | 0 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Bowel ischemia (requiring surgical intervention) | 0 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Paralysis / paraparesis | 0 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Death | 35 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Myocardial infarction | 12 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Stroke | 15 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Procedural blood loss (≥1,000 cc) | 4 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Respiratory failure (requiring mechanical ventilat | 2 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Procedural blood loss (≥1,000 cc) | 4 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Death | 45 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Stroke | 17 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Myocardial infarction | 13 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Respiratory failure (requiring mechanical ventilat | 2 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Paralysis / paraparesis | 0 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | Bowel ischemia (requiring surgical intervention) | 1 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Major Adverse Events (MAEs) and Individual Components of the MAEs | New onset renal failure (requiring dialysis) | 0 Participants |
Secondary
Procedure-related Complications
Adverse events that are a result of the procedure itself.
Time frame: Through 1 month, 180-days, 360-days and annually to 5-years post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Procedure-related Complications | 98 Participants |
| Site-reported Procedure-related AEs Through 180 Days | Procedure-related Complications | 100 Participants |
| Site-reported Procedure-related AEs Through 360 Days | Procedure-related Complications | 104 Participants |
| Site-reported Procedure-related AEs Through 2 Years | Procedure-related Complications | 104 Participants |
| Site-reported Procedure-related AEs Through 3 Years | Procedure-related Complications | 109 Participants |
| Site-reported Procedure-related AEs Through 4 Years | Procedure-related Complications | 112 Participants |
| Site-reported Procedure-related AEs Through 5 Years | Procedure-related Complications | 113 Participants |
Secondary
Technical Success Confirmed by CT or Other Imaging Modality
The study evaluated technical success at 30-days as one of the secondary effectiveness endpoints. The definition of technical success is defined as patency of the endovascular graft, with the absence of Type I or III endoleaks or aneurysm sac rupture, up to 30-days post-procedure completion as confirmed by CT or other imaging modality.
Time frame: At 30-days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Technical Success Confirmed by CT or Other Imaging Modality | 188 Participants |
Other Pre-specified
Pain Post-Operatively
Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time frame: Baseline, 1 month, 6 months and 1 year post-procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Pain Post-Operatively | 71.4 Units on a Scale |
| Site-reported Procedure-related AEs Through 180 Days | Pain Post-Operatively | 70.2 Units on a Scale |
| Site-reported Procedure-related AEs Through 360 Days | Pain Post-Operatively | 71.5 Units on a Scale |
| Site-reported Procedure-related AEs Through 2 Years | Pain Post-Operatively | 73.1 Units on a Scale |
Other Pre-specified
Physical Functioning Post-operatively
Physical Functioning (PF) Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time frame: Screening, 1 month, 6 months and 1 year post-procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Physical Functioning Post-operatively | 69.2 Units on a Scale |
| Site-reported Procedure-related AEs Through 180 Days | Physical Functioning Post-operatively | 66.5 Units on a Scale |
| Site-reported Procedure-related AEs Through 360 Days | Physical Functioning Post-operatively | 68.6 Units on a Scale |
| Site-reported Procedure-related AEs Through 2 Years | Physical Functioning Post-operatively | 68.2 Units on a Scale |