Acute Aortic Dissection, Aortic Arch Aneurysm, Aortic Arch Dissection, Chronic Aortic Dissection
Conditions
Keywords
total arch replacement, frozen elephant trunk, aortic arch aneurysm, aortic arch dissection
Brief 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.
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.
Sponsors
Artivion Inc.
Bright Research Partners
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Primary Arm: chronic aortic dissection or aortic aneurysm. Secondary Arm: acute or subacute aortic dissection
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Rate of Patients Free From ≥1 Major Adverse Event | 1 year post-index procedure of LSA stent graft implant | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Mortality | Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure | All-cause, Cardiovascular-related, Aorta-related, Procedure-related, Device-related |
| Rate of Patients with ≥1 Additional Aortic Procedure | Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index 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 | Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure | 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 | Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure | 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 Radiographic Events (determined by Core Lab) | Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure | 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). |
| Rate of Patients Requiring a Thoracic Extension Procedure who Experience Device-Extension Failure | Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure | 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 |
| Rate of Patient Requiring a Thoracic Extension Procedure with Evidence of Type IIIa Endoleak | Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of index procedure | Type IIIa Endoleak |
| Rate of Patients Requiring Thoracic Extension Procedure with Failed Patency | Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure | Failed patency of the device-extension overlap |
| Rate of Patients Requiring Thoracic Extension Procedure with ≥1 Primary Major Adverse Events | 30 days post-extension procedure | All-cause mortality, new permanent disabling stroke, new permanent paraplegia and/or paraparesis, unanticipated aortic reoperation in the treated segment, LSA occlusion |
| Rate of Patients Requiring Thoracic Extension Procedure Requiring ≥1 Secondary Procedure Related to Extension | 30 days post-extension procedure | Secondary procedures related to the extension |
Countries
United States
Contacts
CONTACTErin M Adams, MSPH
Outcome results
None listed