Arcevo LSA stent graft for repairing aortic arch dissections and aneurysms

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

This trial will test whether the Arcevo LSA stent graft can safely and effectively repair aortic arch and descending thoracic aortic dissections or aneurysms in adults.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Artivion Inc. (industry)
• Locations: 16 sites (Los Angeles, California and 15 other locations)
• Trial ID: NCT07089576 on ClinicalTrials.gov

What this trial studies

This interventional device study implants the Arcevo™ LSA Hybrid Stent Graft System during open surgical repair for patients with acute, subacute, or chronic aortic dissection or aneurysm involving the aortic arch and descending thoracic aorta. Eligible adults (18–80 years) must have preoperative CTA within 90 days and undergo surgery within 90 days of consent, with specific anatomic requirements such as aortic diameter ≥21 mm at the planned LSA anastomosis. Outcomes will focus on procedural safety and technical effectiveness, with follow-up imaging to document sealing and complication rates. The trial is conducted at several academic medical centers in the United States.

Who should consider this trial

Good fit: Adults aged 18–80 with an acute, subacute, or chronic aortic dissection or an aortic arch aneurysm that involves the arch and descending thoracic aorta, with suitable anatomic measurements and planned open surgery within 90 days, are the intended candidates.

Not a fit: Patients with an aortic diameter below the device's anatomical requirements, anatomy not suitable for the device, prohibitive comorbidities, or who cannot undergo surgery at a participating center are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could enable more reliable repair of aortic arch pathology and reduce procedure-related complications for appropriate patients.

How similar studies have performed: Similar hybrid stent-graft and frozen elephant trunk approaches have shown favorable results in prior series, although the Arcevo LSA device itself is relatively new and being specifically tested here.

Eligibility 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 Exclusion Criteria
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

Where this trial is running

Los Angeles, California and 15 other locations

• University of Southern California — Los Angeles, California, United States (RECRUITING)
• University of Colorado Hospital — Aurora, Colorado, United States (RECRUITING)
• Emory University School of Medicine — Atlanta, Georgia, United States (RECRUITING)
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (RECRUITING)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
• University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
• Columbia University Irving Medical Center/New York Presbyterian Hospital — New York, New York, United States (RECRUITING)
• Cornell Medical College (Presbyterian Weill) — New York, New York, United States (RECRUITING)
• Northwell Health — New York, New York, United States (RECRUITING)
• Montefiore Medical Center — The Bronx, New York, United States (RECRUITING)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
• University of Texas - Austin — Austin, Texas, United States (RECRUITING)
• University of Texas, McGovern Medical Center — Houston, Texas, United States (RECRUITING)
• Baylor Scott & White — Plano, Texas, United States (RECRUITING)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)

Study contacts

• Study coordinator: Erin M Adams, MSPH

Conditions: Aortic Arch Aneurysm, Aortic Arch Dissection, Chronic Aortic Dissection, Acute Aortic Dissection, total arch replacement, frozen elephant trunk, aortic arch aneurysm, aortic arch dissection