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NCT Number: NCT07022145

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

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.

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Key information

Conditions

Type B Aortic Dissection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular repair

Procedure

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

Primary outcomes

  1. 30-day Postoperative Positive Remodeling Rate of the Descending Thoracic Aorta

    Time frame: 30 days

    (Number of subjects with positive remodeling of the descending thoracic aorta at the 30-day postoperative visit / Total number of subjects who completed the 30-day postoperative visit) × 100%

  2. 12-month Postoperative Degree of Positive Remodeling of the Descending Thoracic Aorta

    Time frame: 12 months

    Positive aortic remodeling is defined as meeting at least one of the following criteria:

    A reduction in the maximum diameter or volume of the false lumen, accompanied by either a decrease or an increase of less than 5 mm in the total aortic diameter or volume;

    An increase in the maximum diameter or volume of the true lumen, accompanied by either a decrease or an increase of less than 5 mm in the total aortic diameter or volume;

    A reduction in the maximum aortic diameter (along with changes in the diameters of both the true and false lumens).

    Formula for calculating the degree of positive remodeling of the descending thoracic aorta at 12 months postoperatively:

    (Maximum true lumen diameter of the descending thoracic aorta at 12 months post-op / Maximum total lumen diameter at 12 months post-op) - (Preoperative maximum true lumen diameter / Preoperative maximum total lumen diameter of the descending thoracic aorta)

Secondary outcomes

  1. 3-month Postoperative Positive Remodeling Rate of the Descending Thoracic Aorta

    Time frame: 3 months

  2. 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

  3. Rate of Visceral Arterial Branch Lumen Loss During Follow-up

    Time frame: 5 years

  4. 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

  5. All-Cause Mortality Rate During Follow-up

    Time frame: 5 years

  6. Aortic-related Mortality Rate During Follow-up

    Time frame: 5 years

  7. Aortic-related Reintervention Rate During Follow-up

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Yuanqing Kan

CONTACT

[email protected]

+8613585939248

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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