Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA (NCT07089576) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
United States132 participantsStarted 2025-11-04
Plain-language summary
The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and/or aneurysm that involves the aortic arch and the descending thoracic aorta, with or without the involvement of the ascending aorta.
Who can participate
Age range
18 Years – 80 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
. ≥18 years of age or ≤80 years of age (male or female) at time of surgery
. Patient has one of the following indications for open surgery based on computed tomography angiography (CTA) completed within 90 days of informed consent:
. Patient, or patient's legally authorized representative (LAR; in the secondary arm only), provides written informed consent prior to any study procedures
. Patient's surgery occurs within 90 days of informed consent
. Aortic diameter at the intended Arcevo™ LSA anastomosis site is ≥ 21 mm
. For Aneurysm with distal sealing (i.e., single stage procedure), aortic diameter at the intended distal sealing zone is between 20-36 mm
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
Composite Rate of Patients Free From ≥1 Major Adverse Event
Timeframe: 1 year post-index procedure of LSA stent graft implant
. For Dissection with distal sealing, aortic diameter at the intended distal sealing zone is between 22-40 mm
. LSA branch does not require additional stenting further into the LSA (beyond the Arcevo™ LSA)
Exclusion criteria
. Patient is pregnant, or planning to become pregnant during the course of the study; individuals of child-bearing potential must agree to use acceptable methods of contraception during the study
. Patient has another medical condition (aside from the arch disease) that, in the opinion of the investigator, reduces the patient's life expectancy to \< 2 years
. Patient has an existing aortic stent graft device in the descending aorta that would interact with Arcevo™ LSA
. Patient has a medical, social, or psychological problem that, in the opinion of the investigator, could impede the patient's ability to return for follow-up
. Patient is unwilling or unable to comply with the follow-up schedule
. Patient is institutionalized due to administrative or judicial order
. Patient is unwilling to accept blood transfusion or blood product
. Patient is currently participating in another interventional clinical study which includes treatment with another investigational product (e.g., device, pharmaceutical or biologic)