Actively Recruiting
A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery
Led by Fujian Medical University · Updated on 2024-07-09
150
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multicenter, randomized controlled clinical trial plan to evaluate the effectiveness and safety of intraoperative stent system in the treatment of acute type I aortic dissection
CONDITIONS
Official Title
A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with acute type I aortic dissection who need arch repair
- Aged 20 years and older but not older than 65 years
- Acute phase with onset within 14 days before surgery
- Able to understand the purpose of the trial, voluntarily participate, sign informed consent, and willing to accept follow-up
You will not qualify if you...
- Anatomical variations such as aortic arch malformation, aortic coarctation, common origin of innominate artery and left common carotid artery, aberrant right subclavian artery, abnormal origin of left conical artery, stenosis or distortion of branch arteries, or mismatch of aortic arch and branch artery diameters with test device
- Dissection secondary to previous aortic treatment or Marfan syndrome
- Aortic and branch artery lesions causing severe ischemic complications like myocardial ischemia, stroke, paraplegia, mesenteric artery ischemia, or renal artery dysplasia
- Severe uncontrolled infectious lesions
- Need for other concomitant treatments for severe underlying conditions such as hypertension, chronic obstructive pulmonary disease, coronary heart disease, or chronic kidney disease
- Other life-threatening lesions including advanced malignant tumors with expected survival less than one year
- Other heart and aorta diseases requiring concurrent surgery or unsuitable for stent treatment such as peripheral vascular disease and blood diseases
- Participation in other drug or device clinical trials without reaching primary endpoint
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Cardiovascular Surgery
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
L
Liang-wan Chen, M.D Ph.D
CONTACT
X
Xiao-fu Dai, M.D Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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