Actively Recruiting
A Prospective, Multi-center Study to Evaluate the Safety and Effectiveness of Arcevo LSA in Open Repair of Aortic Arch Aneurysms and Dissections
Led by Artivion Inc. · Updated on 2026-05-22
132
Participants Needed
19
Research Sites
221 weeks
Total Duration
On this page
Sponsors
A
Artivion Inc.
Lead Sponsor
B
Bright Research Partners
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Arcevo LSA Hybrid Stent Graft System to see if it can safely and effectively treat patients with acute or chronic aortic dissection and/or aneurysm involving the aortic arch and descending thoracic aorta, with or without the ascending aorta. This clinical study includes patients needing open surgical repair and is sponsored by Artivion Inc. The trial focuses on measuring major adverse events within one year after the stent graft implant. The study involves implanting the Arcevo LSA Hybrid Stent Graft System during an open surgical total arch replacement procedure. This device is preloaded on a delivery system and used with a proximal surgical graft. If needed, an additional thoracic endovascular aortic repair (TEVAR) device may be used for further coverage. The study has two groups: a primary arm for patients with aortic aneurysm or chronic dissection and a secondary arm for those with acute or subacute dissections. Participants will be monitored closely after their surgery, with follow-ups at multiple intervals up to 60 months. Researchers will assess rates of mortality, additional aortic procedures, device-related events, major adverse events, and complications related to extensions of the device. The primary outcome is the rate of patients free from at least one major adverse event one year after the procedure. The total participation period includes detailed safety and effectiveness monitoring over several years.
CONDITIONS
Brief Title
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 80 years old at time of surgery
- Have acute, subacute, or chronic dissection or aneurysm involving the aortic arch and descending thoracic aorta, with or without ascending aorta involvement
- Surgery planned within 90 days of informed consent
- Provide written informed consent (or legally authorized representative consent for secondary arm)
- Aortic diameter at intended Arcevo LSA anastomosis site is at least 21 mm
- For aneurysm cases with distal sealing, aortic diameter between 20-36 mm
- For dissection cases with distal sealing, aortic diameter between 22-40 mm
- LSA branch does not need additional stenting beyond Arcevo LSA
- Intended LSA sealing zone diameter between 8.5 mm and 14.0 mm, with length at least 10 mm
- No dissection, aneurysm, or stenosis in intended LSA sealing zone
- LSA branch position does not block flow to any branch vessel
- No extreme arch or LSA angulation preventing safe device passage
- LSA take-off angle between 15° and 90°
- For planned extension, at least 2 cm distal seal zone for TEVAR device without severe angulation
- For planned extension, suitable iliac artery anatomy for TEVAR delivery system
You will not qualify if you...
- Pregnant or planning to become pregnant during the study; individuals of child-bearing potential must use contraception
- Medical condition reducing life expectancy to less than 2 years (aside from arch disease)
- Existing aortic stent graft in descending aorta that would interfere with Arcevo LSA
- Medical, social, or psychological issues that may prevent follow-up
- Unwilling or unable to comply with follow-up schedule
- Institutionalized due to administrative or judicial order
- Refusal to accept blood transfusion or blood products
- Currently participating in another interventional clinical study with an investigational product
- Unfit for open surgical repair involving circulatory arrest
- Severe hemodynamic compromise requiring CPR or strong inotropic support before surgery
- Active systemic infection
- Endocarditis or active aortic infection
- Freely ruptured aorta
- History of bleeding disorders such as hemophilia
- End-stage renal disease (e.g., GFR less than 30 mL/min)
- Known allergy to components of Arcevo LSA or TEVAR device
- Uncontrollable anaphylaxis to iodinated contrast or inability to obtain CT angiograms during follow-up
- Acute coronary malperfusion
- Symptomatic visceral malperfusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive the Arcevo LSA Hybrid Stent Graft System implanted during an open surgical procedure called total arch replacement.
1 surgical procedure
Duration - Up to hospital discharge
Participants are monitored closely after the implantation surgery for recovery and immediate post-operative care.
Approximately 1 to 2 in-hospital visits
Duration - Up to 60 months post-procedure
Participants undergo follow-up visits to evaluate safety, device performance, and any adverse events related to the surgery and device.
Follow-up visits at 30 days, 6, 12, 24, 36, 48, and 60 months
Trial Site Locations
Total: 19 locations
1
University of Alabama
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
3
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
4
MedStar Washington Health
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
8
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
10
Cornell Medical College (Presbyterian Weill)
New York, New York, United States, 10065
Actively Recruiting
11
Northwell Health
New York, New York, United States, 10075
Actively Recruiting
12
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
13
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
14
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
15
University of Texas - Austin
Austin, Texas, United States, 78705
Actively Recruiting
16
University of Texas, McGovern Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
17
Baylor Scott & White
Plano, Texas, United States, 75093
Actively Recruiting
18
University of Washington / Harborview Medical Center
Seattle, Washington, United States, 98105
Actively Recruiting
19
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
E
Erin M Adams, MSPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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