Research on Predicting Aortic Remodeling Following TEVAR for Type B Aortic Dissection Based on VDM and CFD

NCT07779291 | Completed DMC

• 1 other identifier: 2026-0777
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

This study proposes a retrospective analysis that systematically integrates multidimensional biomechanical and anatomical data to construct an early and accurate predictive model for adverse aortic remodeling following thoracic endovascular aortic repair (TEVAR) in patients with Type B aortic dissection (TBAD). Postoperative follow-up CTA images will be analyzed using vascular deformation mapping (VDM) technology, which enables quantitative assessment of regional aortic deformation and strain evolution through high-precision three-dimensional registration, thereby overcoming the limitations of conventional diameter-based measurements. Concurrently, patient-specific computational fluid dynamics (CFD) models will be reconstructed from preoperative CTA data to simulate the hemodynamic environment within the dissected aorta, extracting key parameters including wall shear stress, flow velocity, and pressure distribution to quantify the mechanical forces driving vascular remodeling. Furthermore, the anatomical characteristics of entry tears-including their number, spatial distribution, and size-will be systematically characterized. By integrating these three dimensions of indicators and employing multivariable regression and machine learning algorithms, independent risk factors significantly associated with adverse events such as false lumen aneurysmal expansion, aortic rupture, and recurrent dissection will be identified, ultimately establishing a comprehensive predictive model that combines sensitivity, objectivity, and clinical feasibility. The development of this model is expected to provide clinicians with quantitative decision support for early identification of high-risk patients, formulation of individualized surveillance strategies, and implementation of timely interventions, thereby substantially improving the long-term prognosis and quality of life for TBAD patients following TEVAR.

Conditions

Type B Aortic Dissection; Tevar; CFD

Keywords

Type B aortic dissection; TEVAR; adverse aortic remodeling; vascular deformation mapping; computational fluid dynamics

Outcome Measures

Primary Outcomes (1)

• Composite of Adverse Aortic Remodeling

  A composite endpoint defined as the occurrence of any of the following events during follow-up: (1) aneurysmal dilation of the stented or distal aorta to ≥5.0 cm; (2) aneurysmal dilation rate ≥0.5 cm/year; (3) rupture or signs of imminent rupture; (4) visceral and/or lower limb malperfusion; (5) distal stent-induced new entry (d-SINE); (6) Type I, II, III, or R endoleak.

  Up to 5 years post-procedure

Secondary Outcomes (6)

• All-Cause Mortality

  Up to 5 years post-procedure

• Aortic-Related Mortality

  Up to 5 years post-procedure

• Aortic-Related Secondary Intervention Rate

  Up to 5 years post-procedure

• Visceral Artery Branch Lumen Loss Rate

  Up to 5 years post-procedure

• False Lumen Thrombosis Status

  Up to 5 years post-procedure

Study Arms (1)

TEVAR-TBAD Cohort

TEVAR using commercially available stent-grafts via femoral access, covering the primary entry tear to promote false lumen thrombosis and aortic remodeling. This single-arm cohort includes acute uncomplicated TBAD patients treated with TEVAR, with adequate pre- and post-operative CTA imaging. Exclusions include connective tissue disorders, traumatic/iatrogenic dissection, PAU/IMH, prior aortic surgery, and insufficient imaging quality. The cohort is analyzed retrospectively using VDM, CFD, and tear morphology to predict adverse remodeling outcomes

Procedure: Thoracic Endovascular Aortic Repair

Interventions

Thoracic Endovascular Aortic Repair PROCEDURE

Thoracic endovascular aortic repair (TEVAR) with commercially available stent-graft devices, implanted via femoral arterial access under fluoroscopic guidance. The intervention involves covering the primary entry tear with a stent-graft to redirect blood flow into the true lumen.

TEVAR-TBAD Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population comprises patients diagnosed with acute uncomplicated Type B aortic dissection who underwent thoracic endovascular aortic repair (TEVAR) at a single center. Eligible patients were aged 18 to 85 years, male or non-pregnant female, and had at least one preoperative and three postoperative CTA examinations with adequate imaging coverage from the brachiocephalic trunk to the iliac arteries. Patients with traumatic or iatrogenic dissection, chronic or complicated dissection, penetrating aortic ulcer (PAU), intramural hematoma (IMH), localized dissection, connective tissue disorders (e.g., Marfan syndrome), prior cardiac or aortic surgery, insufficient imaging quality, or failed image registration for VDM analysis were excluded. A total of 1000 patients were enrolled and followed for up to 5 years post-TEVAR to assess adverse aortic remodeling outcomes.

You may qualify if:

• (1) Age between 18 and 85 years, male or non-pregnant female. (2) CTA-confirmed diagnosis of Type B aortic dissection, classified as acute uncomplicated dissection. (3) Underwent TEVAR (thoracic endovascular aortic repair) procedure. (4) At least one preoperative and three postoperative CTA examinations available, with imaging coverage extending cranially to include the brachiocephalic trunk, left common carotid artery, and the origin of the left subclavian artery, and caudally to cover the origins of the internal and external iliac arteries.

You may not qualify if:

• (1) Age \<18 or \>85 years. (2) Traumatic or iatrogenic dissection, or isolated aortic aneurysm. (3) Chronic or complicated dissection. (4) Penetrating aortic ulcer (PAU) or intramural hematoma (IMH), as well as localized dissection. (5) Connective tissue disorders, such as Marfan syndrome. (6) Prior history of cardiac or aortic surgery. (7) Absence of signed surgical informed consent. (8) Insufficient CTA examinations or inadequate imaging coverage/quality. (9) Failure of image registration precluding completion of the VDM analysis workflow.

Sponsors & Collaborators

• Fudan University: collaborator
• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead
• First Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (3)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)