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

Official title

A Real-World Multicenter, Prospective, Non-Randomized Parallel Controlled Study on the Optimal Endovascular Therapy for Improving Distal Perfusion and Remodeling of Acute Type B Aortic Dissection

Overview

There are both common and individual characteristics in patients with type B aortic dissection. Currently, for all subtypes of acute type B dissection, proximal endovascular repair is mostly performed during the subacute phase, while the distal dissection of the descending aorta is often managed with a "watch and wait" strategy. However, such a uniform approach carries potential risks, including imprecise indications, inappropriate timing, and uncertain prognosis. Our research team has previously established a comprehensive database and imaging repository of nearly 10,000 cases of type B dissection. Building upon existing subtypes-such as acute complicated, uncomplicated, penetrating atherosclerotic ulcer, and intramural hematoma-we have further explored refined classifications, including acute high-risk types and localized contrast enhancement of the aortic wall. For patients with different subtypes and at different stages of dissection-such as hyperacute, acute, or subacute-it is critical to develop individualized treatment strategies. These may include optimal medical therapy, isolated proximal endovascular repair, or combined proximal repair with distal bare stent implantation. Therefore, a large-scale clinical study is urgently needed to identify the optimal timing and approach for intervention based on refined classification schemes, and to establish personalized, stratified treatment strategies for different patient groups. This project aims to conduct a real-world, prospective, multicenter, parallel-controlled study to compare outcomes between isolated proximal endovascular repair and combined proximal repair with distal bare stent implantation in patients with acute complicated or high-risk type B aortic dissection. The goal is to determine the most effective surgical approach for improving distal perfusion and promoting favorable aortic remodeling, thereby guiding treatment decision-making.

Interventions

• Procedure Endovascular repair
  Endovascular repair using proximal stent-graft or proximal stent-graft combined with distal stent for TBAD patients

Primary outcome measures

• 30-day Postoperative Positive Remodeling Rate of the Descending Thoracic Aorta [Time frame: 30 days]
• 12-month Postoperative Degree of Positive Remodeling of the Descending Thoracic Aorta [Time frame: 12 months]

Secondary outcome measures (7)

• 3-month Postoperative Positive Remodeling Rate of the Descending Thoracic Aorta [Time frame: 3 months]
• Incidence of Distal Stent-Induced New Entry (d-SINE) During Follow-up Incidence of Distal Stent-Induced New Entry (d-SINE) During Follow-up Incidence of Distal Stent-Induced New Entry (d-SINE) During Follow-up [Time frame: 5 years]
• Rate of Visceral Arterial Branch Lumen Loss During Follow-up [Time frame: 5 years]
• Degree of Positive Remodeling of the Abdominal Aorta During Follow-up Degree of Positive Remodeling of the Abdominal Aorta During Follow-up Degree of Positive Remodeling of the Abdominal Aorta During Follow-up [Time frame: 5 years]
• All-Cause Mortality Rate During Follow-up [Time frame: 5 years]
• Aortic-related Mortality Rate During Follow-up [Time frame: 5 years]
• Aortic-related Reintervention Rate During Follow-up [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07022145 · 2023ZD-TEVAR-DBS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗