Real-World Prospective Parallel Controlled Study on Endovascular Therapy for Improving Perfusion and Remodeling of TBAD

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Jun 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying different treatment methods for patients with a serious condition called type B aortic dissection, which is when there is a tear in the inner layer of the aorta, the large blood vessel that carries blood from the heart. The researchers want to compare two surgical approaches: one that involves repairing the upper part of the aorta only and another that also includes placing a stent (a small mesh tube) in the lower part of the aorta. The goal is to find out which method works better for improving blood flow and helping the aorta heal.

To participate in this study, you must be an adult aged 18 or older who has been diagnosed with an acute complicated type B aortic dissection or a high-risk type B dissection. This includes patients with severe symptoms or certain conditions that make the dissection more dangerous. Participants will need to understand the study's purpose, agree to take part, and be willing to attend follow-up appointments. The trial is not yet recruiting, but once it starts, it will help doctors learn the best ways to treat this serious condition to improve patient outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male participants aged ≥18 years or non-pregnant female participants
• • Diagnosed with acute complicated type B aortic dissection (defined as rupture/imminent rupture, associated ischemic syndromes \[bowel, renal, or lower limb ischemia\], radiologic progression of dissection or aortic dilation during hospitalization, uncontrolled hypertension, or refractory pain lasting over 12 hours), or high-risk type B dissection (defined as total aortic diameter \>40 mm, false lumen diameter \>22 mm, primary entry tear \>10 mm, entry on the inner curvature, hemothorax, radiologic signs of ischemia \[bowel, renal, or lower limb\], or recurrent pain/symptoms).
• • Patients deemed suitable for TEVAR or TEVAR combined with supra-aortic single-branch endovascular repair, as assessed by the investigator
• • Patients who understand the purpose of the study, voluntarily agree to participate by signing informed consent, and are willing to comply with follow-up requirements
• Exclusion Criteria:
• • Subjects with hemodynamic instability or ruptured aortic dissection
• • Subjects who, due to anatomical factors, are unsuitable for isolated TEVAR or TEVAR combined with supra-aortic single-branch reconstruction
• • Subjects with connective tissue disorders, such as Marfan syndrome
• • Subjects in poor general condition who cannot tolerate general anesthesia
• • Subjects with known allergies to contrast agents or stent materials such as nitinol
• • 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 serum creatinine levels \>2.5 times the upper limit of normal or currently on dialysis
• • Subjects with severe comorbidities such as liver failure