Aortic Aneurysm, Abdominal
Conditions
Keywords
AAA, Abdominal Aortic Aneurysm, EVAR, Endovascular aneurysm repair
Brief summary
The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol. The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality (ARM).
Interventions
The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.
Sponsors
Duke Clinical Research Institute
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
* Age ≥18 years * Indication for elective surgical repair of abdominal aortic aneurysm (AAA) with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System * Signed consent form. The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information * Intention to electively implant the Endurant Stent Graft System * Ability and willingness to comply with the Clinical Investigational Plan (CIP).
Exclusion criteria
* High probability of non-adherence to physician's follow-up requirements * Current participation in a concurrent trial which may confound study results * Female of childbearing potential in whom pregnancy cannot be excluded or who is lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days) | 5 years | Aneurysm-Related Mortality (ARM) is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should be aneurysm related. \> All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine device, procedure and/or AAA relatedness. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ENGAGE PAS De Novo Subjects The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).
\>
\> Endurant Stent Graft System: The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure. | 178 |
| Total | 178 |
Baseline characteristics
| Characteristic | ENGAGE PAS De Novo Subjects |
|---|---|
| Age, Continuous | 71.7 Years STANDARD_DEVIATION 8.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 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 | 169 Participants |
| Region of Enrollment United States | 178 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 48 / 178 |
| other Total, other adverse events | 15 / 178 |
| serious Total, serious adverse events | 86 / 178 |
Outcome results
Primary
Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)
Aneurysm-Related Mortality (ARM) is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should be aneurysm related. \> All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine device, procedure and/or AAA relatedness.
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ENGAGE PAS De Novo Subjects | Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days) | 0.989 Proportion of Surviving |