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
Artivion Inc.
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 rep…
Interventions
- DeviceArcevo™ LSA Hybrid Stent Graft System
The Arcevo LSA Hybrid Stent Graft System is an implantable aortic stent graft with LSA branch which is preloaded onto a delivery system and implanted during an open surgical procedure, or more specifically a total arch replacement procedure. The device is intended for use with a proximal surgical graft (not supplied). If additional coverage is needed, a protocol specified thoracic endovascular aortic repair (TEVAR) device may be used.
Locations (16)
- University of Southern CaliforniaLos Angeles, California
- University of Colorado HospitalAurora, Colorado
- Emory University School of MedicineAtlanta, Georgia
- Northwestern University Feinberg School of MedicineChicago, Illinois
- Johns Hopkins HospitalBaltimore, Maryland
- University of MichiganAnn Arbor, Michigan