A Prospective, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA in the Open Repair of Aortic Arch Aneurysms and Dissections
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.
• ≥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:
‣ 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
• 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
• Anatomical Inclusion Criteria
• 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
• 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)
• The intended LSA sealing zone has a diameter between 8.5 mm and 14.0 mm with a length of at least 10 mm
⁃ Absence of dissection, aneurysm, or stenosis in the intended LSA sealing zone
⁃ The intended LSA branch position does not interrupt flow to any branch vessel (e.g., left vertebral artery)
⁃ Patient does not have computed tomography (CT) evidence of extreme arch or LSA angulation precluding safe passage of the Arcevo™ LSA and delivery system
⁃ LSA take-off angle between 15° and 90°
⁃ For patients requiring planned extension, there is a ≥ 2 cm distal seal zone for the TEVAR device without a severely angulated descending aorta
⁃ For patients requiring planned extension, patient has suitable iliac artery anatomy for safe passage of the TEVAR delivery system