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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChEVAS System | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimney Endovascular Aortic Sealing (ChEVAS) System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-Month |
| 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. | 1-Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Vascular Consultants | Huntsville | Alabama | 35801 | United States | ||
| MedStar Health Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2019 |
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|
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| St Vincent Medical Group | Indianapolis | Indiana | 46260 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10019 | United States |
| Providence Portland | Portland | Oregon | 97213 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 1-Month |
|
|
| |||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 1-Year |
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1 Year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 13 | 4 | 13 | 6 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Systematic Assessment |
| ||
| Compartment Syndrome | Surgical and medical procedures | Systematic Assessment |
| ||
| Neurological | Nervous system disorders | Systematic Assessment |
| ||
| Endoleak Type 1A | Vascular disorders | Systematic Assessment |
| ||
| Miscellaneous- Inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding/Anemia | Surgical and medical procedures | Systematic Assessment |
| ||
| Cardiac | Cardiac disorders | Systematic Assessment |
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| Miscellaneous | General disorders | Systematic Assessment |
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| Nellix Device | Product Issues | Systematic Assessment |
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| Surgical Site Wound | Surgical and medical procedures | Systematic Assessment |
| ||
| Vascular | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Moawad | Endologix | 949-595-7244 | mmoawad@endologix.com |
| Nov 27, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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