1 Paravisceral Abdominal Aortic Aneurysm, 2 Juxtarenal Abdominal Aortic Aneurysm, 3 Pararenal Abdominal Aortic Aneurysm, 4 Complex Abdominal Aortic Aneurysms
Conditions
Keywords
Paravisceral Abdominal Aortic Aneurysm, Juxtarenal Abdominal Aortic Aneurysm, Pararenal Abdominal Aortic Aneurysm, Complex Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm
Brief summary
Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.
Detailed description
This is a prospective multicenter study with consecutive eligible subject enrollment at each site. Enrollment will include up to 150 subjects (120 ChEVAS subjects and up to 30 infrarenal roll-in subjects). The ChEVAS study will evaluate the safety and effectiveness outcomes following appropriate government and ethics committee/IRB requirements and guidelines. All enrolled (ChEVAS and Infrarenal) subjects will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30-days, 6-months, and annually to 5-years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results. \*As of October 27, 2021 ChEVAS ONE Study is voluntarily closed to screening and consenting. 13 subjects enrolled in the study will continue to be observed through 5-years.
Interventions
DEVICEChimney Endovascular Aortic Sealing (ChEVAS) System
The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
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
* Adults at least 18-years old * Subject provided informed consent * Subject agrees to all follow-up visits * Abdominal aortic aneurysm (AAA) with maximum sac diameter ≥5.0 cm, or ≥ 4.5 cm which has increased by ≥ 0.5cm within the last 6-months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA \<4cm will be included * Absence of significant cranial angulation of the visceral vessels that would preclude vessel cannulation and stenting
Exclusion criteria
* Requirement of home oxygen * Psychiatric or other condition that may interfere with the study * Participating in another clinical drug and/or device study, which could confound the results of this study (patient must have completed the primary endpoint of any previous study at least 30-days prior to enrollment in this study) * Known allergy or contraindication to any device material, contrast, or anticoagulants * Serum creatinine level \>1.8mg/dL * CVA or MI within three months of enrollment/treatment * Prior stent in any target visceral vessel, the aorta or iliac artery that may interfere with delivery system introduction or stent placement * Connective tissue diseases (e.g., Marfan Syndrome) * Unsuitable vascular anatomy that may interfere with device introduction or deployment * Pregnant, planning to become pregnant within 60 months, or breast feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure | 1-Month | The outcome at one-month post index procedure will be measured by the proportion of subjects that experience technical success and the absence of severe bowel ischemia, permanent paraplegia/paraparesis, renal failure, disabling stroke, abdominal aortic aneurysm rupture, and aneurysm-related mortality within 30-days of the index procedure. |
| Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure | 1-Year | The outcome at one-year post index procedure will be measured by the proportion of subjects that experience freedom from abdominal aortic aneurysm rupture and aneurysm-related mortality up until 1-year (day 365), freedom from imaging-related findings in the 1-year window (Type 1 or 3 endoleak, migration \> 10mm, AAA sac expansion \> 5mm, and occlusion within the ChEVAS System not seen at the index procedure), and open conversion through day 365. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ChEVAS System The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
Chimney Endovascular Aortic Sealing (ChEVAS) System: The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | ChEVAS System |
|---|---|
| Age, Continuous | 74 years STANDARD_DEVIATION 4 |
| Race/Ethnicity, Customized Caucasian | 8 Participants |
| Race/Ethnicity, Customized Non-Caucasian | 5 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 6 / 13 |
| serious Total, serious adverse events | 4 / 13 |
Outcome results
Primary
Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure
The outcome at one-year post index procedure will be measured by the proportion of subjects that experience freedom from abdominal aortic aneurysm rupture and aneurysm-related mortality up until 1-year (day 365), freedom from imaging-related findings in the 1-year window (Type 1 or 3 endoleak, migration \> 10mm, AAA sac expansion \> 5mm, and occlusion within the ChEVAS System not seen at the index procedure), and open conversion through day 365.
Time frame: 1-Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ChEVAS System | Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure | 10 Participants |
Primary
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure
The outcome at one-month post index procedure will be measured by the proportion of subjects that experience technical success and the absence of severe bowel ischemia, permanent paraplegia/paraparesis, renal failure, disabling stroke, abdominal aortic aneurysm rupture, and aneurysm-related mortality within 30-days of the index procedure.
Time frame: 1-Month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ChEVAS System | Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure | 13 Participants |