Abdominal Aortic Aneurysm
Conditions
Keywords
Powerlink, 34mm, Abdominal Aortic Aneurysm, EVAR
Brief summary
Study of anatomical fixation with a 34mm proximal extension
Detailed description
The 34mm proximal extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.
Interventions
DEVICEEndologix Powerlink 34 mm stent graft cuff
Endovascular abdominal aortic aneurysm repair
Sponsors
Endologix
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
* 18 years old or older * Informed consent understood and signed * Will comply with protocol follow-up requirements * Candidate for conventional open surgical repair * Aneurysm outer diameter is one or more of the following: * greater than or equal to 4.0cm * greater than or equal to 3.0cm (saccular aneurysm) * greater than or equal to twice the normal aortic outer diameter * rapidly growing (greater than or equal to 5mm over 6 months) * Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm * Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm * Iliac artery internal diameter greater than or equal to 8 mm
Exclusion criteria
* Life expectancy \<2 years * Participating in another clinical study * Pregnant or lactating women * Acutely ruptured/leaking aneurysm * Traumatic vascular injury * Other medical or psychiatric problems * Contraindication to non-ionic contrast media or anticoagulants * Coagulopathy or bleeding disorder * Active systemic or localized groin infection * Indispensable inferior mesenteric artery * Connective tissue disease (e.g., Marfan's Syndrome) * Creatinine level \>1.7 mg/dl * Renal transplant patient * Proximal attachment site \>60º angle to the aneurysm body * Iliac arteries \>90º angle * \<1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides \[One internal iliac artery is required to remain patent\] * Thrombus \>30% at implantation site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Proximal Type I Endoleak at Each Timepoint | Five years | Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Type III Endoleaks at Each Timepoint | 5 Years | Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab. |
| Number of Participants With Stent Fracture at Each Timepoint | 5 Years | Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab. |
| Number of Participants With Stent Graft Obstruction at Each Timepoint | 5 Years | Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab. |
| Number of Participants With Migration at Each Timepoint | 5 Years | Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab. |
| Number of Participants With Successful Delivery and Deployment of the Device | 1 Month | Successful delivery and deployment of the device with no complication. |
| Number of Participants With Aneurysm Diameter Change at Each Timepoint | 5 Years | Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab. |
| Maximum Diameter Measurements | 5 Years | Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months). |
| Aneurysm Volume Measurements | 5 Years | Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab. |
| Number of Participants With Type II Endoleaks at Each Timepoint | 5 Years | Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff: Endovascular abdominal aortic aneurysm repair | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy |
|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 8.3 |
| Aneurysm Diameter Distribution <30mm | 0 Participants |
| Aneurysm Diameter Distribution 30mm to 39mm | 0 Participants |
| Aneurysm Diameter Distribution 40mm to 49mm | 2 Participants |
| Aneurysm Diameter Distribution 50mm to 59mm | 14 Participants |
| Aneurysm Diameter Distribution 60mm to 69mm | 2 Participants |
| Aneurysm Diameter Distribution 70mm to 79mm | 0 Participants |
| Aneurysm Diameter Distribution >79mm | 1 Participants |
| Mean Aneurysm Measurements Distall non-aneurysmal left iliac diameter | 13 mm STANDARD_DEVIATION 2.6 |
| Mean Aneurysm Measurements Distal non-aneurysmal neck diameter | 31 mm STANDARD_DEVIATION 1.4 |
| Mean Aneurysm Measurements Distal non-aneurysmal right iliac diameter | 13 mm STANDARD_DEVIATION 2.3 |
| Mean Aneurysm Measurements External Iliac Diameter | 9.3 mm STANDARD_DEVIATION 1.2 |
| Mean Aneurysm Measurements Left Distal Seal Zone Length | 38 mm STANDARD_DEVIATION 13 |
| Mean Aneurysm Measurements Length Proximal Neck to Distal Left Iliac | 169 mm STANDARD_DEVIATION 23 |
| Mean Aneurysm Measurements Length Proximal Neck to Distal Right Iliac | 171 mm STANDARD_DEVIATION 23 |
| Mean Aneurysm Measurements Length Proximal Neck to Left Proximal Iliac | 122 mm STANDARD_DEVIATION 21 |
| Mean Aneurysm Measurements Maximum Aneurysm Diameter | 57 mm STANDARD_DEVIATION 12 |
| Mean Aneurysm Measurements Proximal non-aneurysmal left iliac diameter | 15 mm STANDARD_DEVIATION 3.4 |
| Mean Aneurysm Measurements Proximal non-aneurysmal neck diameter | 28 mm STANDARD_DEVIATION 1.9 |
| Mean Aneurysm Measurements Proximal non-aneurysmal right iliac diameter | 15 mm STANDARD_DEVIATION 2.7 |
| Mean Aneurysm Measurements Proximal Seal Zone lenght | 27 mm STANDARD_DEVIATION 11 |
| Mean Aneurysm Measurements Right Distal Seal Zone Length | 41 mm STANDARD_DEVIATION 13 |
| Medical History Angina | 2 Participants |
| Medical History Arrhythmia | 6 Participants |
| Medical History CABG | 3 Participants |
| Medical History Cancer | 4 Participants |
| Medical History Cerebrovascular Disease | 6 Participants |
| Medical History Coagulopathy | 1 Participants |
| Medical History Congestive Heart Failure | 3 Participants |
| Medical History COPD | 11 Participants |
| Medical History Coronary artery Disease | 10 Participants |
| Medical History Diabetes | 3 Participants |
| Medical History Family History of AAA | 3 Participants |
| Medical History Gastrointestinal abnormality | 7 Participants |
| Medical History Hypercholesterolemia | 14 Participants |
| Medical History Hypertension | 17 Participants |
| Medical History Liver Disease | 0 Participants |
| Medical History Peripheral Occlusive Arterial Disease | 9 Participants |
| Medical History Prio MI (< 6 mo) | 0 Participants |
| Medical History Prio MI (>6 mo) | 1 Participants |
| Medical History Prior Abdominal Surgery | 7 Participants |
| Medical History PTCA/Stent | 4 Participants |
| Medical History Renal Failure | 1 Participants |
| Medical History Smoking (ever) | 19 Participants |
| Medical History Valve Replacement | 1 Participants |
| Medical History Valvular Disease | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 19 |
| other Total, other adverse events | 7 / 19 |
| serious Total, serious adverse events | 14 / 19 |
Outcome results
Primary
Number of Participants With Proximal Type I Endoleak at Each Timepoint
Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).
Time frame: Five years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Proximal Type I Endoleak at Each Timepoint | Discharge | 1 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Proximal Type I Endoleak at Each Timepoint | 1 Month | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Proximal Type I Endoleak at Each Timepoint | 6 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Proximal Type I Endoleak at Each Timepoint | 12 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Proximal Type I Endoleak at Each Timepoint | 24 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Proximal Type I Endoleak at Each Timepoint | 48 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Proximal Type I Endoleak at Each Timepoint | 60 Months | 0 Participants |
Secondary
Aneurysm Volume Measurements
Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab.
Time frame: 5 Years
Population: Results are provided as the number of events over the number of patients with the follow-up image available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Aneurysm Volume Measurements | 1 Month | 213 cm3 | Standard Deviation 136 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Aneurysm Volume Measurements | 6 Months | 217 cm3 | Standard Deviation 136 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Aneurysm Volume Measurements | 12 Months | 213 cm3 | Standard Deviation 136 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Aneurysm Volume Measurements | 24 Months | 164 cm3 | Standard Deviation 49 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Aneurysm Volume Measurements | 36 Months | 163 cm3 | Standard Deviation 51 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Aneurysm Volume Measurements | Pre-operative | 203 cm3 | Standard Deviation 125 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Aneurysm Volume Measurements | 48 Months | 166 cm3 | Standard Deviation 60 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Aneurysm Volume Measurements | 60 Months | 161 cm3 | Standard Deviation 47 |
Secondary
Maximum Diameter Measurements
Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months).
Time frame: 5 Years
Population: Results are provided as the number of events over the number of patients with the follow-up image available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Maximum Diameter Measurements | 24 Months | 52 mm | Standard Deviation 17 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Maximum Diameter Measurements | Pre-operative | 56 mm | Standard Deviation 15 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Maximum Diameter Measurements | 1 Month | 57 mm | Standard Deviation 15 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Maximum Diameter Measurements | 6 Months | 56 mm | Standard Deviation 16 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Maximum Diameter Measurements | 12 Months | 56 mm | Standard Deviation 18 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Maximum Diameter Measurements | 36 Months | 46 mm | Standard Deviation 8 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Maximum Diameter Measurements | 48 Months | 45.5 mm | Standard Deviation 9 |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Maximum Diameter Measurements | 60 Months | 47.3 mm | Standard Deviation 13 |
Secondary
Number of Participants With Aneurysm Diameter Change at Each Timepoint
Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab.
Time frame: 5 Years
Population: Results are provided as the number of events over the number of patients with the follow-up image available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 6 Months | Stable | 11 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 6 Months | Increase | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 24 Months | Increase | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 6 Months | Decrease | 3 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 12 Months | Decrease | 3 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 12 Months | Stable | 9 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 12 Months | Increase | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 24 Months | Decrease | 6 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 24 Months | Stable | 10 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 36 Months | Decrease | 6 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 36 Months | Stable | 3 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 36 Months | Increase | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 48 Months | Decrease | 4 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 48 Months | Stable | 3 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 48 Months | Increase | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 60 Months | Decrease | 3 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 60 Months | Stable | 2 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Aneurysm Diameter Change at Each Timepoint | 60 Months | Increase | 1 Participants |
Secondary
Number of Participants With Migration at Each Timepoint
Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab.
Time frame: 5 Years
Population: Results are provided as the number of events over the number of patients with the follow-up image available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Migration at Each Timepoint | 1 Month | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Migration at Each Timepoint | 6 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Migration at Each Timepoint | 12 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Migration at Each Timepoint | 24 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Migration at Each Timepoint | 36 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Migration at Each Timepoint | 48 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Migration at Each Timepoint | 60 Months | 0 Participants |
Secondary
Number of Participants With Stent Fracture at Each Timepoint
Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab.
Time frame: 5 Years
Population: Results are provided as the number of events over the number of patients with the follow-up image available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Fracture at Each Timepoint | Discharge | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Fracture at Each Timepoint | 1 Month | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Fracture at Each Timepoint | 6 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Fracture at Each Timepoint | 12 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Fracture at Each Timepoint | 24 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Fracture at Each Timepoint | 36 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Fracture at Each Timepoint | 48 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Fracture at Each Timepoint | 60 Months | 0 Participants |
Secondary
Number of Participants With Stent Graft Obstruction at Each Timepoint
Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab.
Time frame: 5 Years
Population: Results are provided as the number of events over the number of patients with the follow-up image available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Graft Obstruction at Each Timepoint | 1 Month | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Graft Obstruction at Each Timepoint | 6 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Graft Obstruction at Each Timepoint | 12 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Graft Obstruction at Each Timepoint | 24 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Graft Obstruction at Each Timepoint | 36 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Graft Obstruction at Each Timepoint | 48 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Stent Graft Obstruction at Each Timepoint | 60 Months | 0 Participants |
Secondary
Number of Participants With Successful Delivery and Deployment of the Device
Successful delivery and deployment of the device with no complication.
Time frame: 1 Month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Successful Delivery and Deployment of the Device | 19 Participants |
Secondary
Number of Participants With Type II Endoleaks at Each Timepoint
Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
Time frame: 5 Years
Population: Results are provided as the number of events over the number of patients with the follow-up image available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type II Endoleaks at Each Timepoint | 1 Month | 4 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type II Endoleaks at Each Timepoint | 6 Months | 2 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type II Endoleaks at Each Timepoint | 12 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type II Endoleaks at Each Timepoint | 24 Months | 2 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type II Endoleaks at Each Timepoint | 36 Months | 1 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type II Endoleaks at Each Timepoint | 48 Months | 1 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type II Endoleaks at Each Timepoint | 60 Months | 0 Participants |
Secondary
Number of Participants With Type III Endoleaks at Each Timepoint
Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
Time frame: 5 Years
Population: Results are provided as the number of events over the number of patients with the follow-up image available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type III Endoleaks at Each Timepoint | 60 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type III Endoleaks at Each Timepoint | 1 Month | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type III Endoleaks at Each Timepoint | 6 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type III Endoleaks at Each Timepoint | 12 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type III Endoleaks at Each Timepoint | 24 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type III Endoleaks at Each Timepoint | 36 Months | 0 Participants |
| Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Number of Participants With Type III Endoleaks at Each Timepoint | 48 Months | 0 Participants |