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NCT07022145

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

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

438

Start Date

2025-06

Completion Date

2030-05

Last Updated

2025-06-15

Healthy Volunteers

No

Interventions

PROCEDURE

Endovascular repair

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