NCT Number: NCT07779291
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.
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Notify Me18 year–85 year
All sexes
Observational
Zhongshan Hospital, Fudan University, Shanghai, Shanghai Municipality, China
Inclusion criteria
(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.
Exclusion criteria
(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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(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.
Exclusion criteria
(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.
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.
Time frame: Up to 5 years post-procedure
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.
Time frame: Up to 5 years post-procedure
Death from any cause during follow-up.
Time frame: Up to 5 years post-procedure
Death related to progression of aortic dissection or complications following TEVAR during follow-up.
Time frame: Up to 5 years post-procedure
Rate of secondary interventions related to progression of aortic dissection or complications from the initial TEVAR procedure. Indications for secondary intervention include: Type I/III endoleak, Type II endoleak with concomitant false lumen aneurysmal dilation, retrograde Type A dissection (RTAD), distal stent-induced new entry (d-SINE) causing pain or persistent false lumen perfusion, distal aneurysmal dilation, and left subclavian artery (LSA) steal syndrome due to LSA coverage during the initial intervention. Secondary intervention strategies include: endovascular approaches (repeat stent-graft implantation, branch artery stenting, chimney/periscope techniques, coil embolization) and open surgical approaches (artificial vascular graft replacement, supra-aortic or visceral branch artery bypass/transposition).
Time frame: Up to 5 years post-procedure
Rate of visceral artery branch lumen loss during follow-up, assessed by serial CTA imaging.
Time frame: Up to 5 years post-procedure
Degree of false lumen thrombosis assessed by serial CTA imaging during follow-up. Thrombosis status is categorized based on the extent of thrombus formation within the false lumen.
Time frame: Up to 5 years post-procedure
Rate of aortic-related adverse events (AAEs) during follow-up. AAEs are defined as a composite of: aortic-related death, major adverse cardiovascular events, stroke, acute renal insufficiency, rupture, spinal cord ischemia, mesenteric ischemia, lower limb ischemia, retrograde Type A dissection (RTAD), distal stent-induced new entry (d-SINE), stent-graft migration, stent-graft infection, and access site complications.
Second Affiliated Hospital, Zhejiang University, School of Medicine
Other
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