New device aims to improve survival in aortic arch surgery
NCT ID NCT07089576
First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study tests a new device called the Arcevo LSA Hybrid Stent Graft, used during open surgery to repair the aortic arch in people with aneurysms or dissections. The device is implanted to support the aorta and its left subclavian artery branch. Researchers will track safety and effectiveness in 132 participants over time, watching for serious events like stroke, paralysis, or death.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Arcevo LSA Hybrid Stent Graft System (a device implanted during open surgery to repair the aortic arch)
- What this could lead to
- If successful, this device could provide a safer, more effective way to repair life-threatening aortic arch aneurysms and dissections during open surgery.
- What could go wrong
- This is an early-stage study with only 132 participants, so results may not apply to everyone. Risks include stroke, paralysis, or need for additional surgery.
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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About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jul 2032
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 to 80 years
- 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.
General Inclusion Criteria 1. ≥18 years of age or ≤80 years of age (male or female) at time of surgery 2. Patient has one of the following indications for open surgery based on computed tomography angiography (CTA) completed within 90 days of informed consent: * Acute, subacute, or chronic dissection that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending aorta * Aneurysm that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending aorta 3. Patient, or patient's legally authorized representative (LAR; in the secondary arm only), provides written informed consent prior to any study procedures 4. Patient's surgery occurs within 90 days of informed consent Anatomical Inclusion Criteria 5. Aortic diameter at the intended Arcevo™ LSA anastomosis site is ≥ 21 mm 6. For Aneurysm with distal sealing (i.e., single stage procedure), aortic diameter at the intended distal sealing zone is between 20-36 mm 7. For Dissection with distal sealing, aortic diameter at the intended distal sealing zone is between 22-40 mm 8. LSA branch does not require additional stenting further into the LSA (beyond the Arcevo™ LSA) 9. The intended LSA sealing zone has a diameter between 8.5 mm and 14.0 mm with a length of at least 10 mm 10. Absence of dissection, aneurysm, or stenosis in the intended LSA sealing zone 11. The intended LSA branch position does not interrupt flow to any branch vessel (e.g., left vertebral artery) 12. Patient does not have computed tomography (CT) evidence of extreme arch or LSA angulation precluding safe passage of the Arcevo™ LSA and delivery system 13. LSA take-off angle between 15° and 90° 14. For patients requiring planned extension, there is a ≥ 2 cm distal seal zone for the TEVAR device without a severely angulated descending aorta 15. For patients requiring planned extension, patient has suitable iliac artery anatomy for safe passage of the TEVAR delivery system General Exclusion Criteria 1. 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 2. 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 3. Patient has an existing aortic stent graft device in the descending aorta that would interact with Arcevo™ LSA 4. 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 5. Patient is unwilling or unable to comply with the follow-up schedule 6. Patient is institutionalized due to administrative or judicial order 7. Patient is unwilling to accept blood transfusion or blood product 8. Patient is currently participating in another interventional clinical study which includes treatment with another investigational product (e.g., device, pharmaceutical or biologic) Medical Exclusion Criteria 9. Patient is unfit for open surgical repair involving circulatory arrest 10. Patient is in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) or substantial inotropic support prior to surgery 11. Patient has an active systemic infection 12. Patient has endocarditis or active infection of the aorta 13. Patient has a freely ruptured aorta 14. Patient has a history of a bleeding disorder (e.g., hemophilia) 15. Patient has current end-stage renal disease (e.g., GFR \<30 mL/min) 16. Patient has a known allergy to Arcevo™ LSA components and TEVAR device components (if required) (nitinol, polyester, platinum-iridium, or polyethylene) 17. Patient has uncontrollable anaphylaxis to iodinated contrast or other inability to obtain CT angiograms during follow-up 18. Patient has acute coronary malperfusion 19. Patient has symptomatic visceral malperfusion
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
21 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Allegheny General Hospital
RECRUITINGPittsburgh, Pennsylvania, 15212, United States
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Baylor Scott & White
RECRUITINGPlano, Texas, 75093, United States
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Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
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Columbia University Irving Medical Center/New York Presbyterian Hospital
RECRUITINGNew York, New York, 10032, United States
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Cornell Medical College (Presbyterian Weill)
RECRUITINGNew York, New York, 10065, United States
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Emory University School of Medicine
RECRUITINGAtlanta, Georgia, 30322, United States
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Jefferson Health
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 21287, United States
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MedStar Washington Health
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10467, United States
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Northwell Health
RECRUITINGNew York, New York, 10075, United States
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Northwestern University Feinberg School of Medicine
RECRUITINGChicago, Illinois, 60611, United States
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University of Alabama
RECRUITINGBirmingham, Alabama, 35205, United States
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University of Colorado Hospital
RECRUITINGAurora, Colorado, 80045, United States
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University of Florida-Shands
RECRUITINGGainesville, Florida, 32608, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Southern California
RECRUITINGLos Angeles, California, 90033, United States
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University of Texas - Austin
RECRUITINGAustin, Texas, 78705, United States
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University of Texas, McGovern Medical Center
RECRUITINGHouston, Texas, 77030, United States
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University of Washington / Harborview Medical Center
RECRUITINGSeattle, Washington, 98105, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Simple blood tests may reveal who needs closer monitoring after aortic tear surgery
- New stent grafts aim to fix aortic aneurysms without major surgery
- Aortic Stent-Graft safety under the microscope: 600-Patient european registry launches
- New stent aims to fix deadly aortic aneurysms without open surgery
- New study tracks kidney health after aortic stent surgery
- Less invasive Stent-Graft aims to fix dangerous aortic bulges