New stent device aims to fix Hard-to-Treat aortic aneurysms
NCT ID NCT04252573
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new device called the ChEVAS System for people with complex abdominal aortic aneurysms (bulges in the main blood vessel near the kidneys). The device is placed inside the blood vessel using a catheter, avoiding open surgery. Only 13 people are enrolled, and researchers will check safety and effectiveness at 1 month and 1 year. This is an early, small study, so results are preliminary.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ChEVAS System (a device that combines a stent graft with chimney stents to repair complex aortic aneurysms)
- What this could lead to
- If successful, this device could offer a less invasive way to treat complex aortic aneurysms that are hard to operate on, potentially reducing recovery time and complications.
- What could go wrong
- This is a very small, early study with only 13 people and no comparison group. The device may not work as hoped, and there are serious risks like kidney failure, stroke, or bowel damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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13 people
The number who actually took part.
- Started
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Jun 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cooper University Hospital
Camden, New Jersey, 08103, United States
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Emory University
Atlanta, Georgia, 30322, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10019, United States
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MedStar Health Research Institute
Washington D.C., District of Columbia, 20010, United States
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Providence Portland
Portland, Oregon, 97213, United States
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St Vincent Medical Group
Indianapolis, Indiana, 46260, United States
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University of Missouri
Columbia, Missouri, 65212, United States
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Valley Vascular Consultants
Huntsville, Alabama, 35801, United States