Aortic Arch AneurysmARTIZENNCT07089576
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
A study testing Arcevo™ LSA Hybrid Stent Graft System in people with Aortic Arch Aneurysm and Aortic Arch Dissection, run by Artivion Inc. at 26 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Arch Aneurysm, Aortic Arch Dissection, Chronic Aortic Dissection
- What is being tested?
- Arcevo™ LSA Hybrid Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 26 sitesin 3 countries
- Study dates
- 4 Nov 2025to Jul 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
General Inclusion Criteria
- ≥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 Anatomical Inclusion Criteria
- 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°
- For patients requiring planned extension, there is a ≥ 2 cm distal seal zone for the TEVAR device without a severely angulated descending aorta
- For patients requiring planned extension, patient has suitable iliac artery anatomy for safe passage of the TEVAR delivery system
General Exclusion Criteria
- 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) Medical Exclusion Criteria
- 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)
- Patient has a known allergy to Arcevo™ LSA components and TEVAR device components (if required) (nitinol, polyester, platinum-iridium, or polyethylene)
- Patient has uncontrollable anaphylaxis to iodinated contrast or other inability to obtain CT angiograms during follow-up
- Patient has acute coronary malperfusion
- Patient has symptomatic visceral malperfusion
Trial locations and contacts
26 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 3 countries
United States22 sites, 22 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
China Green, 734-936-7731, chigreen@med.umich.edu
Shinichi Fukuhara, MD
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30322
Kim Baio, 404-686-3374, kbaio@emory.edu
Bradley Leshnower, MD
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Tien Ngo, 303-724-5020, tien.ngo@cuanschutz.edu
T. Brett Reece, MD
- Recruiting
University of Texas - Austin
Austin, Texas, 78705
Andrea Stapper, MBA, 512-324-1000 ext. 18734, andrea.stapper@ascension.org
George Arnaoutakis, MD
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Lisa Fornaresio, 443-927-3984, Lisa.fornaresio@jhmi.edu
Mehrdad Ghoreishi, MD
- Recruiting
University of Alabama
Birmingham, Alabama, 35205
Marissa Waite, 205-659-5660, mwaite@uabmc.edu
Kyle Eudailey, MD
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Andrea Silverman, 312-926-4000, andrea.silverman@nm.org
Christopher Malaisrie, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Laurie Moennich, PhD, 216-444-2106, moennil@ccf.org
Patrick Vargo, MD, FACS
- Recruiting
University of Florida-Shands
Gainesville, Florida, 32608
Jessica Cobb, 352-273-7837, jessica.cobb@surgery.ufl.edu
Eric Jeng, MD
- Recruiting
University of Texas, McGovern Medical Center
Houston, Texas, 77030
Mariano Montemayor, 713-486-5194, Mariano.R.Montemayor@uth.tmc.edu
Anthony Estrera, MD
- Recruiting
University of Southern California
Los Angeles, California, 90033
Stephanie Varela, 213-655-0998, stephanie.varela@med.usc.edu
Fernando Fleischman, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kelly Potzner, 414-955-1848, kpotzner@mcw.edu
Jorge Mascaro, MD
- Recruiting
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Amanda Alonso, 212-342-0261, aa2974@cumc.columbia.edu
Hiroo Takayama, MD, PhD
- Recruiting
Cornell Medical College (Presbyterian Weill)
New York, New York, 10065
Marshagay Rodriguez, 212-746-5594, mar4028@med.cornell.edu
Christopher Lau, MD
- Recruiting
Northwell Health
New York, New York, 10075
Michelle Vovsha, 212-434-2726, mvovsha@northwell.edu
Derek Brinster, MD
- Recruiting
Jefferson Health
Philadelphia, Pennsylvania, 19107
Meckenzie Behr, 610-653-5709, meckenzie.behr@jefferson.edu
Cecillia Chin, MD
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Tracy Spirk, 412-359-4025, tracy.spirk@ahn.org
Michael Halbreiner, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Kristin Konopka, 724-448-9518, valcharka@upmc.edu
Derek Serna-Gallegos, MD
- Recruiting
Baylor Scott & White
Plano, Texas, 75093
Walter Cerqueira, 469-814-3393, walter.cerqueira@bswhealth.org
Bill Brinkman, MD
- Recruiting
University of Washington / Harborview Medical Center
Seattle, Washington, 98105
Alex Ruiz, 206-221-3883, aruiz06@uw.edu
Chris Burke, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Magdalena Mamczur-Madry, 718-920-3576, mmamczur@montefiore.org
Joseph DeRose, MD
- Recruiting
MedStar Washington Health
Washington D.C., District of Columbia, 20010
Katharine Mahoney, 202-877-2806, katharine.e.mahoney@medstar.net
Christian Shults, MD
Germany3 sites, 3 recruiting
- Recruiting
Deutsches Herzzentrum der Charité
Berlin, 13353
Ms. Mirjam Gördes, 0049 30 4593 2214, studien-dhzc@dhzc-charite.de
Prof. Jörg Kempfert, MD
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Gabriele Lechner, 0049 761 270 61960, gabriele.lechner@uniklinik-freiburg.de
Martin Czerny, MD
- Recruiting
Herzzentrum Leipzig GmbH, Universitätsklinik für Herzchirurgie
Leipzig, 04289
Eva Kirchhof, 0049 341 865 251597, clinicaltrialsmanagement@helios-health-institute.com
Michael Borger, MD
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola-Malpighi
Bologna, 40138
Marco Pitrelli, 0039 388 3084470, marco.pitrelli@aosp.bo.it
Davide Pacini, MD
About this study
Official title: 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
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
- Being tested
- Arcevo™ LSA Hybrid Stent Graft System
- Keywords
- total arch replacement, frozen elephant trunk, aortic arch aneurysm, aortic arch dissection
- Medical subject headings
- Aneurysm, Aortic Arch, Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arcevo™ LSA Hybrid Stent Graft SystemDevice
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Arcevo™ LSA Hybrid Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year post-index procedure of LSA stent graft implant
Secondary outcomes (10)
Rate of Mortality
All-cause, Cardiovascular-related, Aorta-related, Procedure-related, Device-related
Measured: 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
All unplanned aortic procedures (endovascular, percutaneous, and open), Unanticipated aortic reoperations in the treated segment, Unanticipated device-related reoperations, Arcevo LSA explant
Measured: 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
Device migration, Distal stent-induced new entry (d-SINE), Failed stent patency in the main body, Failed stent patency in the LSA, Stent-graft integrity issue compromising flow (i.e., stent fracture, narrowing, kink, or twist)
Measured: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients with Major Adverse Events
New permanent paraplegia, New permanent paraparesis, New temporary paraplegia, New disabling stroke, New non-disabling stroke, New transient ischemic attack, Aortic rupture, Bowel ischemia, Hypersensitivity, Myocardial infarction, New onset renal failure requiring temporary dialysis, New onset renal failure requiring permanent dialysis, Pseudoaneurysm, Recurrent laryngeal or phrenic nerve injury, Respiratory failure (need for reintubation or ventilator dependence >48 hours), Severe heart failure requiring mechanical circulatory support, Thromboembolic adverse events
Measured: 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)
Anastomotic Leak between Arcevo™ LSA and surgical graft (i.e., Type Ia Endoleak or Distal anastomotic new entry [DANE]), Type Ic Endoleak (i.e. at the end of the LSA stent component), LSA occlusion, New LSA dissection, Maximal total aortic diameter growth >1 cm in the treated segment (Zones 2-4) compared to first post-operative CTA, Maximal total aortic diameter growth >1 cm at 1 cm beyond the distal end of Arcevo™ LSA, compared annually.
Dissection Only:
True lumen (TL) reduction compared to baseline > 5.0 mm at maximal total aortic diameter (Zones 2-4), False lumen (FL) growth compared to baseline > 5.0 mm at maximal total aortic diameter (Zones 2-4), FL thrombosis in the treated segment (LSA, Zones 2-4), FL thrombosis in the untreated segment (Zone 5).
Measured: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients Requiring a Thoracic Extension Procedure who Experience Device-Extension Failure
Any failure of device-extension integrity (e.g., wear or tear in the fabric or wire breakage) resulting in a compromised seal and blood leakage or movement of the device
Measured: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patient Requiring a Thoracic Extension Procedure with Evidence of Type IIIa Endoleak
Type IIIa Endoleak
Measured: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of index procedure
Rate of Patients Requiring Thoracic Extension Procedure with Failed Patency
Failed patency of the device-extension overlap
Measured: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients Requiring Thoracic Extension Procedure with ≥1 Primary Major Adverse Events
All-cause mortality, new permanent disabling stroke, new permanent paraplegia and/or paraparesis, unanticipated aortic reoperation in the treated segment, LSA occlusion
Measured: 30 days post-extension procedure
Rate of Patients Requiring Thoracic Extension Procedure Requiring ≥1 Secondary Procedure Related to Extension
Secondary procedures related to the extension
Measured: 30 days post-extension procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start4 Nov 2025
- Primary completionApr 2028 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Arch AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Primary Arm: chronic aortic dissection or aortic aneurysm. Secondary Arm: acute or subacute aortic dissection
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artivion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089576
- Sponsor's protocol ID
- ART2401.000-C
- Acronym
- ARTIZEN
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No