Conventional TEVAR Versus FABULOUS RCT (NCT06740565) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Conventional TEVAR Versus FABULOUS RCT
392 participantsStarted 2025-02-01
Plain-language summary
For High-risk Type B aortic dissections, a multicenter, prospective, randomized controlled study is conducted to compare the clinical outcomes of conventional proximal endovascular repair (TEVAR) alone versus the Fabulous system which includes a proximal stent graft with a distal bare metal stent implanted. The study aims to determine the optimal intervention method for such population.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males aged 18 years or older, or non-pregnant females
* Diagnosed with high-risk Type B aortic dissection with a narrow true lumen (defined as the minimum true lumen diameter being less than 30% of the total vessel diameter) and/or poor radiographic or clinical visceral perfusion (including abnormal blood supply to the liver, kidneys, mesentery, or lower limb ischemia)
* Deemed suitable for endovascular treatment according to the investigator's judgment
* Able to understand the purpose of the trial, willing to participate voluntarily and sign the informed consent form, and committed to follow-up visits.
Exclusion Criteria:
* • Subjects with hemodynamic instability or ruptured aortic dissection
* Subjects who, due to various anatomical factors, are unable to undergo TEVAR alone
* Subjects with connective tissue diseases, such as Marfan syndrome
* Subjects in poor general condition, unable to tolerate general anesthesia
* Subjects allergic to contrast agents, nitinol stent materials, or other stent components
* Subjects with a life expectancy of less than 12 months
* Subjects with a history of myocardial infarction or unstable angina within the past 3 months
* Subjects with a history of TIA or cerebral infarction within the past 3 months
* Subjects with creatinine levels exceeding 2.5 times the upper normal limit or those currently on dialysis
* Subjects with severe conditions such as liver failure