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

NCT ID: NCT07022145

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 438 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2030-05-31

Brief Summary

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.

Conditions

Type B Aortic Dissection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

PSG

Type B aortic dissection patients treated with proximal stent-graft

Endovascular repair

Intervention Type: PROCEDURE

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

PSG+DBS

Type B aortic dissection patients treated with proximal stent-graft combined with distal bare stent

Endovascular repair

Intervention Type: PROCEDURE

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

Interventions

Endovascular repair

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhihui Dong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yuanqing Kan

Role: CONTACT

echok624@gmail.com

+8613585939248

Other Identifiers

2023ZD-TEVAR-DBS

Identifier Type: -

Identifier Source: org_study_id