1 Paravisceral Abdominal Aortic AneurysmChEVAS OneNCT04252573
Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication
A study testing Chimney Endovascular Aortic Sealing (ChEVAS) System in people with 1 Paravisceral Abdominal Aortic Aneurysm and 2 Juxtarenal Abdominal Aortic Aneurysm, run by Endologix at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 1 Paravisceral Abdominal Aortic Aneurysm, 2 Juxtarenal Abdominal Aortic Aneurysm, 3 Pararenal Abdominal Aortic Aneurysm
- What is being tested?
- Chimney Endovascular Aortic Sealing (ChEVAS) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Jun 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University
Atlanta, Georgia, 30322
Cooper University Hospital
Camden, New Jersey, 08103
University of Missouri
Columbia, Missouri, 65212
Valley Vascular Consultants
Huntsville, Alabama, 35801
St Vincent Medical Group
Indianapolis, Indiana, 46260
Icahn School of Medicine at Mount Sinai
New York, New York, 10019
Providence Portland
Portland, Oregon, 97213
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Prospective, Multicenter, Non-randomized Study With Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms.
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.
Read the 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.
- Conditions
- 1 Paravisceral Abdominal Aortic Aneurysm, 2 Juxtarenal Abdominal Aortic Aneurysm, 3 Pararenal Abdominal Aortic Aneurysm, 4 Complex Abdominal Aortic Aneurysms
- Being tested
- Chimney Endovascular Aortic Sealing (ChEVAS) System
- Keywords
- Paravisceral Abdominal Aortic Aneurysm, Juxtarenal Abdominal Aortic Aneurysm, Pararenal Abdominal Aortic Aneurysm, Complex Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimney Endovascular Aortic Sealing (ChEVAS) SystemDevice
Also called ChEVAS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Chimney Endovascular Aortic Sealing (ChEVAS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start29 Jun 2020
- Primary completion19 Oct 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 1 Paravisceral Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252573
- Sponsor's protocol ID
- CP-0015
- Acronym
- ChEVAS One
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2020
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Non-randomized Study With Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms.
- ClinicalTrials.gov ID
- NCT04252573
- Acronym / sponsor ID
- ChEVAS One / CP-0015
- Conditions
- 1 Paravisceral Abdominal Aortic Aneurysm, 2 Juxtarenal Abdominal Aortic Aneurysm, 3 Pararenal Abdominal Aortic Aneurysm, 4 Complex Abdominal Aortic Aneurysms
- Keywords
- Paravisceral Abdominal Aortic Aneurysm, Juxtarenal Abdominal Aortic Aneurysm, Pararenal Abdominal Aortic Aneurysm, Complex Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ChEVAS System | Experimental | Device: Chimney Endovascular Aortic Sealing (ChEVAS) SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chimney Endovascular Aortic Sealing (ChEVAS) SystemAlso: ChEVASThe 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. | Device | ChEVAS System |
Primary outcome
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chimney Endovascular Aortic Sealing (ChEVAS) System in people with 1 Paravisceral Abdominal Aortic Aneurysm and 2 Juxtarenal Abdominal Aortic Aneurysm, run by Endologix at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure (time frame: 1-Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.