Conventional TEVAR Versus FABULOUS RCT
ConditionType B Aortic Dissection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
• 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
Trial design
Treatments tested in this trial
- thoracic endovascular aortic repair
Treatment groups
392 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov