Actively Recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Led by W.L.Gore & Associates · Updated on 2026-04-14
112
Participants Needed
16
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
CONDITIONS
Official Title
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with de novo Type A aortic dissection within 30 days (primary arm) or 90 days (secondary arm) from symptom onset to procedure
- Intended treatment by placement of the ASG device in the ascending aorta
- Anatomic compatibility of the ascending aorta including specific landing zone requirements and aortic diameter between 27mm and 48mm
- Considered high-risk for open surgical repair by the Aortic Treatment Team meeting at least one of the following: age 280 years, BMI 235 kg/m2, respiratory insufficiency, prior cardiac surgery, hostile chest, clinical frailty scale 3-7 (primary) or 3-9 (secondary), clinical malperfusion, inability to receive transfusions, renal dialysis, or chronic renal insufficiency
- Age 18 years or older at informed consent
- Adequate vascular access via transfemoral or retroperitoneal approach
- Signed informed consent form
- Agrees to comply with protocol requirements including imaging and 5-year follow-up
You will not qualify if you...
- Mechanical heart valve in the aortic position
- Aortic insufficiency grade 3 or greater confirmed before implant
- Presence of indwelling intravascular devices interfering with planned repair
- Known degenerative connective tissue disease such as Marfan's or Ehler-Danlos syndrome
- Participation in another investigational study within one year unless approved
- History of drug abuse within one year affecting follow-up
- Pregnant at time of procedure
- Active infected aorta or mycotic aneurysm
- Active systemic infection requiring treatment
- Life expectancy less than 12 months due to other conditions
- Known allergies to device materials or contraindications to anticoagulants or contrast media
- Coronary malperfusion
- Severe neurological complications or coma within 30 days prior to diagnosis
- Aortic fistula
- Circulatory shock or extreme hemodynamic compromise before procedure
- Signs of bowel infarction, hemorrhage, or necrosis before procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
3
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Northwestern Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Corewell Health System
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
10
Washington University School of Medicine - St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
12
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
13
Ohio Health Research Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
14
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 18104
Actively Recruiting
15
The Methodist Hospital Houston
Houston, Texas, United States, 77030
Actively Recruiting
16
Baylor Research Institute
Plano, Texas, United States, 75093
Actively Recruiting
Research Team
C
Clinical Study Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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