Actively Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Led by Artivion Inc. · Updated on 2026-04-21
132
Participants Needed
16
Research Sites
347 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
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
Official Title
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years at time of surgery
- Diagnosed with acute, subacute, or chronic dissection involving the aortic arch and descending thoracic aorta, with or without ascending aorta involvement, based on CT angiography within 90 days
- Diagnosed with aneurysm involving the aortic arch and descending thoracic aorta, with or without ascending aorta involvement, based on CT angiography within 90 days
- Provide written informed consent prior to any study procedures
- Undergo surgery within 90 days of informed consent
- Aortic diameter at intended Arcevo LSA anastomosis site is at least 21 mm
- For aneurysm with distal sealing, aortic diameter at intended distal sealing zone is 20-36 mm
- For dissection with distal sealing, aortic diameter at intended distal sealing zone is 22-40 mm
- Left subclavian artery (LSA) branch does not require additional stenting beyond the Arcevo LSA
- Intended LSA sealing zone diameter between 8.5 mm and 14.0 mm and 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
- Suitable iliac artery anatomy for safe passage of TEVAR delivery system if extension planned
You will not qualify if you...
- Pregnant or planning pregnancy during the study; must use contraception if of child-bearing potential
- Medical condition reducing life expectancy to less than 2 years
- Existing aortic stent graft device in descending aorta that may 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 investigational treatments
- Unfit for open surgery involving circulatory arrest
- In extreme hemodynamic compromise needing CPR or strong inotropic support before surgery
- Active systemic infection
- Endocarditis or active infection of the aorta
- Freely ruptured aorta
- History of bleeding disorder such as hemophilia
- End-stage renal disease (e.g., GFR less than 30 mL/min)
- Known allergy to components of Arcevo LSA or TEVAR devices
- Uncontrollable anaphylaxis to iodinated contrast or inability to obtain CT angiograms
- Acute coronary malperfusion
- Symptomatic visceral malperfusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
8
Cornell Medical College (Presbyterian Weill)
New York, New York, United States, 10065
Actively Recruiting
9
Northwell Health
New York, New York, United States, 10075
Actively Recruiting
10
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
11
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
13
University of Texas - Austin
Austin, Texas, United States, 78705
Actively Recruiting
14
University of Texas, McGovern Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Baylor Scott & White
Plano, Texas, United States, 75093
Actively Recruiting
16
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
E
Erin M Adams, MSPH
CONTACT
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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