Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
NCT ID: NCT07089576
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
132 participants
INTERVENTIONAL
2025-11-04
2032-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arcevo LSA
The Primary study arm will consist of patients with an aortic aneurysm or chronic aortic dissection (n=117).
The Secondary study arm will include patients with acute or subacute aortic dissections (n=15).
Arcevo™ 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.
Interventions
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Arcevo™ 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.
Eligibility Criteria
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Inclusion Criteria
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
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
Exclusion Criteria
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)
9. Patient is unfit for open surgical repair involving circulatory arrest
10. Patient is in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) or substantial inotropic support prior to surgery
11. Patient has an active systemic infection
12. Patient has endocarditis or active infection of the aorta
13. Patient has a freely ruptured aorta
14. Patient has a history of a bleeding disorder (e.g., hemophilia)
15. Patient has current end-stage renal disease (e.g., GFR \<30 mL/min)
16. Patient has a known allergy to Arcevo™ LSA components and TEVAR device components (if required) (nitinol, polyester, platinum-iridium, or polyethylene)
17. Patient has uncontrollable anaphylaxis to iodinated contrast or other inability to obtain CT angiograms during follow-up
18. Patient has acute coronary malperfusion
19. Patient has symptomatic visceral malperfusion
18 Years
80 Years
ALL
No
Sponsors
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Bright Research Partners
INDUSTRY
Artivion Inc.
INDUSTRY
Responsible Party
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Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Laurie Moennich, PhD
Role: primary
Other Identifiers
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ART2401.000-C
Identifier Type: -
Identifier Source: org_study_id