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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
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.
University of Southern California
Los Angeles, California, United States
RECRUITINGColumbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
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
Time frame: 1 year post-index procedure of LSA stent graft implant
Rate of Mortality
All-cause, Cardiovascular-related, Aorta-related, Procedure-related, Device-related
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
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
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
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)
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cleveland Clinic Foundation
Cleveland, Ohio, United States
RECRUITINGUniversity of Texas - Austin
Austin, Texas, United States
RECRUITINGBaylor Scott & White
Plano, Texas, United States
RECRUITINGMedical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITINGTime frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients with Radiographic Events (determined by Core Lab)
Anastomotic Leak between Arcevo™ LSA and surgical graft (i.e., Type Ia Endoleak or Distal anastomotic new entry \[DANE\]), Type Ic Endoleak (i.e. at the end of the LSA stent component), LSA occlusion, New LSA dissection, Maximal total aortic diameter growth \>1 cm in the treated segment (Zones 2-4) compared to first post-operative CTA, Maximal total aortic diameter growth \>1 cm at 1 cm beyond the distal end of Arcevo™ LSA, compared annually. Dissection Only: True lumen (TL) reduction compared to baseline \> 5.0 mm at maximal total aortic diameter (Zones 2-4), False lumen (FL) growth compared to baseline \> 5.0 mm at maximal total aortic diameter (Zones 2-4), FL thrombosis in the treated segment (LSA, Zones 2-4), FL thrombosis in the untreated segment (Zone 5).
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients Requiring a Thoracic Extension Procedure who Experience Device-Extension Failure
Any failure of device-extension integrity (e.g., wear or tear in the fabric or wire breakage) resulting in a compromised seal and blood leakage or movement of the device
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patient Requiring a Thoracic Extension Procedure with Evidence of Type IIIa Endoleak
Type IIIa Endoleak
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of index procedure
Rate of Patients Requiring Thoracic Extension Procedure with Failed Patency
Failed patency of the device-extension overlap
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients Requiring Thoracic Extension Procedure with ≥1 Primary Major Adverse Events
All-cause mortality, new permanent disabling stroke, new permanent paraplegia and/or paraparesis, unanticipated aortic reoperation in the treated segment, LSA occlusion
Time frame: 30 days post-extension procedure
Rate of Patients Requiring Thoracic Extension Procedure Requiring ≥1 Secondary Procedure Related to Extension
Secondary procedures related to the extension
Time frame: 30 days post-extension procedure