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

NCT07022145 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 438

Last updated 2025-06-15

No results posted yet for this study

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

Interventions

PROCEDURE

Endovascular repair

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

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-05-31
Completion
2030-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07022145 on ClinicalTrials.gov