Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA

NCT07089576 | Recruiting DMC FDA Device

• 1 other identifier: ART2401.000-C
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 16

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.

Conditions

Aortic Arch Aneurysm; Aortic Arch Dissection; Chronic Aortic Dissection; Acute Aortic Dissection

Keywords

total arch replacement; frozen elephant trunk; aortic arch aneurysm; aortic arch dissection

Outcome Measures

Primary Outcomes (1)

• Composite Rate of Patients Free From ≥1 Major Adverse Event

  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

  1 year post-index procedure of LSA stent graft implant

Secondary Outcomes (10)

• Rate of Mortality

  Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure

• 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

• 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

• Rate of Patients with Major Adverse Events

  Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure

• 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

Other Outcomes (3)

• Rate of Patients with Technical Success

  At exit from operating room

• Rate of Patients with Procedural Success

  At hospital discharge or at 30 days, whichever is longer at time of event

• Rate of Patients with Treatment Success

  Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure

Study Arms (1)

Arcevo LSA

EXPERIMENTAL

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).

Device: Arcevo™ LSA Hybrid Stent Graft System

Interventions

Arcevo™ LSA Hybrid Stent Graft System DEVICE

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.

Arcevo LSA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age or ≤80 years of age (male or female) at time of surgery
• 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
• Patient, or patient's legally authorized representative (LAR; in the secondary arm only), provides written informed consent prior to any study procedures
• Patient's surgery occurs within 90 days of informed consent
• Aortic diameter at the intended Arcevo™ LSA anastomosis site is ≥ 21 mm
• For Aneurysm with distal sealing (i.e., single stage procedure), aortic diameter at the intended distal sealing zone is between 20-36 mm
• For Dissection with distal sealing, aortic diameter at the intended distal sealing zone is between 22-40 mm
• LSA branch does not require additional stenting further into the LSA (beyond the Arcevo™ LSA)
• The intended LSA sealing zone has a diameter between 8.5 mm and 14.0 mm with a length of at least 10 mm
• Absence of dissection, aneurysm, or stenosis in the intended LSA sealing zone
• The intended LSA branch position does not interrupt flow to any branch vessel (e.g., left vertebral artery)
• Patient does not have computed tomography (CT) evidence of extreme arch or LSA angulation precluding safe passage of the Arcevo™ LSA and delivery system
• LSA take-off angle between 15° and 90°

You may not qualify if:

• 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
• 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
• Patient has an existing aortic stent graft device in the descending aorta that would interact with Arcevo™ LSA
• 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
• Patient is unwilling or unable to comply with the follow-up schedule
• Patient is institutionalized due to administrative or judicial order
• Patient is unwilling to accept blood transfusion or blood product
• Patient is currently participating in another interventional clinical study which includes treatment with another investigational product (e.g., device, pharmaceutical or biologic)
• Patient is unfit for open surgical repair involving circulatory arrest
• Patient is in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) or substantial inotropic support prior to surgery
• Patient has an active systemic infection
• Patient has endocarditis or active infection of the aorta
• Patient has a freely ruptured aorta
• Patient has a history of a bleeding disorder (e.g., hemophilia)
• Patient has current end-stage renal disease (e.g., GFR \<30 mL/min)

Sponsors & Collaborators

• Artivion Inc.: lead
• Bright Research Partners: collaborator

Study Sites (16)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Cornell Medical College (Presbyterian Weill)

New York, New York, 10065, United States

RECRUITING

Northwell Health

New York, New York, 10075, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

University of Texas - Austin

Austin, Texas, 78705, United States

RECRUITING

University of Texas, McGovern Medical Center

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott & White

Plano, Texas, 75093, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Aneurysm, Aortic Arch; Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome

Central Study Contacts

Erin M Adams, MSPH

CONTACT

800-438-8285; ARTIZEN@artivion.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Primary Arm: chronic aortic dissection or aortic aneurysm. Secondary Arm: acute or subacute aortic dissection

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 28, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2032
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)