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Recruiting Not applicable

Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA

NCT07089576 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2025-11-04
Last updated
2026-10-15

Condition(s) studied

Aortic Arch AneurysmAortic Arch DissectionChronic Aortic DissectionAcute Aortic Dissection

Investigational drug(s) / intervention(s)

Arcevo™ LSA Hybrid Stent Graft System

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (26)

FacilityCityRegionStatus
University of Alabama Birmingham Alabama Recruiting
University of Southern California Los Angeles California Recruiting
University of Colorado Hospital Aurora Colorado Recruiting
MedStar Washington Health Washington D.C. District of Columbia Recruiting
University of Florida-Shands Gainesville Florida Recruiting
Emory University School of Medicine Atlanta Georgia Recruiting
Northwestern University Feinberg School of Medicine Chicago Illinois Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Columbia University Irving Medical Center/New York Presbyterian Hospital New York New York Recruiting
Cornell Medical College (Presbyterian Weill) New York New York Recruiting
Northwell Health New York New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
Jefferson Health Philadelphia Pennsylvania Recruiting
Allegheny General Hospital Pittsburgh Pennsylvania Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
University of Texas - Austin Austin Texas Recruiting
University of Texas, McGovern Medical Center Houston Texas Recruiting
Baylor Scott & White Plano Texas Recruiting
University of Washington / Harborview Medical Center Seattle Washington Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Deutsches Herzzentrum der Charité Berlin Germany Recruiting
Universitätsklinikum Freiburg Freiburg im Breisgau Germany Recruiting
Herzzentrum Leipzig GmbH, Universitätsklinik für Herzchirurgie Leipzig Germany Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola-Malpighi Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07089576 on ClinicalTrials.gov ↗ ← All trials in Germany