Actively Recruiting
Evaluation of the GORE4 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the GORE4 Ascending Stent Graft (ASG) device for treating new cases of Type A aortic dissections in patients who are considered high-risk for traditional open surgery. This prospective, multicenter, non-randomized, single-arm study focuses on patients with dissections diagnosed within 30 days (primary arm) or up to 90 days (secondary arm) from symptom onset. The study aims to provide insights into endovascular treatment options for this serious condition. The study involves placing the ASG device in the ascending aorta to repair the dissection. The primary arm includes patients with dissections up to 30 days old, treated with the ASG device alone, while the secondary arm includes patients up to 90 days old who may receive the ASG device alone or combined with another device called the TBE device for more complex cases. Additional procedures not involving the ASG device may be performed during the initial treatment at the investigator's discretion. Participants will have regular follow-up visits, including imaging assessments and evaluations over a five-year period to monitor safety and effectiveness. The main outcomes measured are safety and effectiveness within 30 days after treatment, with secondary outcomes assessed at one year. The study requires participants to consent to follow-up imaging and evaluations as their condition permits, helping researchers understand the long-term impact of this endovascular approach for high-risk patients.
CONDITIONS
Brief 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...
- Adults aged 18 years or older at the time of informed consent
- New (de novo) Type A aortic dissection diagnosed within 30 days for the primary arm or within 90 days for the secondary arm
- Intended treatment by placement of the GORE4 Ascending Stent Graft device in the ascending aorta
- Anatomic compatibility of the ascending aorta for implanting the device, including specific landing zone and diameter requirements
- Considered high-risk for open surgical repair by the Aortic Treatment Team, meeting at least one specified risk factor such as age 80 or older, high BMI, respiratory insufficiency, prior cardiac surgery, hostile chest, clinical frailty, malperfusion, no transfusion possibility, renal dialysis, or chronic renal insufficiency
- Adequate vascular access via transfemoral or retroperitoneal approach
- Signed informed consent form
- Agreement to comply with study requirements including imaging and 5-year follow-up as condition allows
You will not qualify if you...
- Mechanical heart valve in the aortic position
- Aortic insufficiency grade 3 or greater confirmed before implant
- Indwelling intravascular devices that interfere with treatment
- Known degenerative connective tissue diseases such as Marfan's or Ehler-Danlos Syndrome
- Participation in another investigational drug or device study within one year unless approved
- History of drug abuse within one year affecting follow-up ability
- Pregnancy at time of procedure
- Active infected aorta or mycotic aneurysm
- Active systemic infection requiring intravenous treatment
- Life expectancy less than 12 months due to other conditions
- Known allergies or sensitivities to device materials, anticoagulants, or contrast media not manageable by pre-treatment
- Coronary malperfusion
- Recent severe neurological complications or coma
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with immediate post-procedure care
Participants receive endovascular aortic repair of the ascending aorta using the GORE® Ascending Stent Graft device.
1 procedure visit (in-person)
Duration - Up to 5 years
Participants are monitored through imaging and assessments to evaluate safety and effectiveness of the device over time.
Periodic visits as specified by study requirements
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
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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