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.
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
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
Single group
Arcevo™ LSA Hybrid Stent Graft System
DeviceThe 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.
Composite Rate of Patients Free From ≥1 Major Adverse Event
The major adverse events included in the composite are: * All-cause mortality * New permanent disabling stroke * New permanent paraplegia and/or paraparesis * Unanticipated aortic reoperation in the treated segment * LSA occlusion
Rate of Mortality
All-cause, Cardiovascular-related, Aorta-related, Procedure-related, Device-related
Rate of Patients with ≥1 Additional Aortic Procedure
All unplanned aortic procedures (endovascular, percutaneous, and open), Unanticipated aortic reoperations in the treated segment, Unanticipated device-related reoperations, Arcevo LSA explant
Rate of Patients with ≥1 Device-Related Event
Device migration, Distal stent-induced new entry (d-SINE), Failed stent patency in the main body, Failed stent patency in the LSA, Stent-graft integrity issue compromising flow (i.e., stent fracture, narrowing, kink, or twist)
Rate of Patients with Major Adverse Events
New permanent paraplegia, New permanent paraparesis, New temporary paraplegia, New disabling stroke, New non-disabling stroke, New transient ischemic attack, Aortic rupture, Bowel ischemia, Hypersensitivity, Myocardial infarction, New onset renal failure requiring temporary dialysis, New onset renal failure requiring permanent dialysis, Pseudoaneurysm, Recurrent laryngeal or phrenic nerve injury, Respiratory failure (need for reintubation or ventilator dependence \>48 hours), Severe heart failure requiring mechanical circulatory support, Thromboembolic adverse events
Rate of Patients with Technical Success
Successful delivery and accurate placement of the device in the intended implantation site, as well as retrieval of the device delivery system, AND Patency of the device, including LSA, at conclusion of the procedure, AND No need for unanticipated or emergency surgery to correct a device malfunction or device-related complication
Rate of Patients with Procedural Success
Technical success with the absence of the following: Death, Major adverse ischemic events, including the following: New disabling stroke, New paraplegia, New paraparesis, New device-related ischemia (i.e., not evident at time of index procedure), Distal procedure-related thromboembolic adverse event. General procedure-related complications: New onset renal failure requiring dialysis, Bowel or limb ischemia requiring surgery or intervention, Additional unplanned surgical or interventional procedures related to the device, since completion of the index procedure
Rate of Patients with Treatment Success
Technical success with the absence of the following: Aorta-related mortality. Major adverse ischemic events, including the following: New disabling stroke, New permanent paraplegia, New permanent paraparesis, Increase in total aortic diameter \> 1.0 cm between scheduled post-operative imaging (performed per schedule of activities) in the treated region of the aorta (Zones 2-4), Aortic rupture, Fistula formation (i.e., aortobronchial or aortoenteric), Device-related occlusion of the aortic arch (Zones 2-4), Loss of device integrity (e.g., stent fracture that could affect fixation or seal, graft fabric hole or tear, collapse), New Type Ic endoleak.
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Artivion Inc.
Lead sponsor
Bright Research Partners
Collaborator
