Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication (NCT04252573) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication
United States13 participantsStarted 2020-06-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure
Timeframe: 1-Month
2
Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure