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NCT07089576NARecruiting

Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA

Artivion Inc.

Start Date

11/4/2025

Completion Date

7/1/2032

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DEVICE

Arcevo™ LSA Hybrid Stent Graft System

Interested in This Trial?

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Conditions

Aortic Arch AneurysmAortic Arch DissectionChronic Aortic DissectionAcute Aortic Dissection

Locations

University of Alabama

Birmingham, Alabama 35205

United States

University of Southern California

Los Angeles, California 90033

United States

University of Colorado Hospital

Aurora, Colorado 80045

United States

MedStar Washington Health

Washington D.C., District of Columbia 20010

United States

University of Florida-Shands

Gainesville, Florida 32608

United States

Emory University School of Medicine

Atlanta, Georgia 30322

United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois 60611

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York 10032

United States

Cornell Medical College (Presbyterian Weill)

New York, New York 10065

United States

Northwell Health

New York, New York 10075

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Jefferson Health

Philadelphia, Pennsylvania 19107

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

University of Texas - Austin

Austin, Texas 78705

United States

University of Texas, McGovern Medical Center

Houston, Texas 77030

United States

Baylor Scott & White

Plano, Texas 75093

United States

University of Washington / Harborview Medical Center

Seattle, Washington 98105

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States