Triple-branch Stent Graft Placement and Total-arch Replacement for the Treatment of Acute DeBakey… (NCT02622750) | Clinical Trial Compass
UnknownEarly Phase 1
Triple-branch Stent Graft Placement and Total-arch Replacement for the Treatment of Acute DeBakey I Aortic Dissection
China90 participantsStarted 2016-11-01
Plain-language summary
The purpose of this study is to compare triple-branched stent placement with total-arch replacement in the treatment of acute DeBakey I aortic dissection . The investigators design optimal effect compare prospective, multi-center, randomized, open-label, parallel-group, non-inferiority clinical trial.
Who can participate
Age range20 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age\<65 years
* acute DeBakkey I aortic dissection is confirmed by CTA
* cardiac function is NYHA I-II
* the onset time\< 2 weeks
* the patient or family members can understand the research plan and will participate in this study and provide a written informed consent
Exclusion Criteria:
* Dissection involved the superior mesenteric artery, renal artery and coronary artery, which affect the body's viscera function seriously. The principal researcher from different centre need judge the patients' condition.
* there is a serious complication of nervous system, such as coma, paraplegia, etc
* pregnant or lactating women
* anyone with severe emphysema, interstitial pneumonia or ischemic heart disease cannot tolerate surgery
* subjects with contraindications of heart surgery, anesthesia and extracorporeal circulation
* subjects had significant or progressive of heart disease, according to the experience of the researchers,whose life expectancy is less than 1 year, or placement of triple- branched stent graft will induce unacceptable risk to the subjects
* anyone with serious mental illness, drug abuse, alcoholism, prison inmates, a lack of ability to care for, or can not express the informed consent
* subjects are incompliance or can't complete the research
* anyone is involved in the other clinical trial
* other reasons are not suitable for clinical trials, according to the researchers