Conventional TEVAR Versus FABULOUS RCT

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Dec 15, 2024

Keywords

ClinConnect Summary

This clinical trial, called the FABULOUS study, is looking at two different treatment options for patients with high-risk Type B aortic dissection, a serious condition affecting the aorta. The trial aims to compare the standard treatment, which involves a procedure called TEVAR (a type of endovascular repair), to a new approach using a special system that includes both a stent graft and a bare metal stent. The goal is to find out which method provides better outcomes for patients.

To be eligible for this study, participants must be at least 18 years old and diagnosed with high-risk Type B aortic dissection. They should have certain conditions that make them suitable for the trial, such as a narrow true lumen (the opening in the aorta) or poor blood flow to vital organs. Participants will need to be willing to understand the study, sign a consent form, and attend follow-up visits. However, those with severe health issues, recent heart problems, or certain anatomical challenges will not be eligible. The trial is not yet recruiting participants, but it represents an important step in improving treatments for this serious condition.

Gender

ALL

Eligibility criteria

• 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