Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA

Launched by ARTIVION INC. · Jul 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called the Arcevo LSA stent graft, which is designed to treat people with problems affecting the aortic arch—the part of the main artery coming out of the heart. Specifically, it’s for patients who have a tear (dissection) or a bulging (aneurysm) in this area, whether the problem is recent or has been there for some time. The goal is to see if this device can be safely used during surgery and if it effectively helps fix these serious heart-related issues.

People who might be eligible for this study are adults between 18 and 80 years old who need open surgery for aortic arch problems confirmed by recent imaging tests. Their aorta size and shape must fit certain measurements to make sure the device can be placed safely. Participants will have surgery using the Arcevo LSA device and then follow-up appointments to check their recovery and how well the device is working. It’s important to know that not everyone can join—for example, those with infections, certain allergies, or other serious health issues may not qualify. This study is not yet recruiting patients but aims to offer a new treatment option for those with complex aortic conditions.

Gender

ALL

Eligibility criteria

• • 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