Indication and Application:
Evaluation of Thoracic Endovascular Aortic Repair (TEVAR) devices and stent grafts, validation of anti-hypertensive and anti-fibrotic pharmacological interventions, and research on MMP-mediated aortic wall remodeling.
Modeling Method:
Chemical Induction (Rodents): Administration of Beta-aminopropionitrile (BAPN) combined with subcutaneous Angiotensin II infusion to trigger spontaneous aortic dissection, simulating connective tissue fragility and hypertension.
Surgical/Catheter-based Induction (Large Animal): Precise mechanical disruption of the tunica media via balloon catheter or blunt surgical entry, allowing for the simulation of localized dissection for the testing of endovascular stents and sealants.
Clinical Relevance:
Pathological Fidelity: The model accurately reproduces the structural degradation of the aortic media and the formation of a false lumen, which is the hallmark of human aortic dissection.
Platform for TEVAR Validation: Large animal models are optimized to match human aortic dimensions, providing a clinically relevant environment to assess the deployment, radial force, and sealing capability of thoracic endovascular grafts.
Key Evaluation Endpoints:
In Vivo / Surgical / Imaging:
CT Angiography (CTA): The gold standard for visualizing the dissection flap, false lumen size, and aortic diameter progression.
Intravascular Ultrasound (IVUS): Real-time assessment of the dissection entry tear and apposition of stent-grafts to the aortic wall.
Hemodynamic Monitoring: Continuous blood pressure and pulse wave velocity monitoring to assess aortic stiffness.
Histopathology:
Morphometry: Verhoeff-Van Gieson (VVG) or Movat's Pentachrome staining to quantify elastic fiber degradation and medial thinning.
Tissue Integrity: Assessment of the dissection flap, hematoma organization, and the effectiveness of neointimal coverage over device surfaces.
IHC: Analysis of vascular smooth muscle cell (VSMC) phenotype switching and inflammatory cell infiltration (CD68, MAC-2).
Molecular:
Expression profiling of Matrix Metalloproteinases (MMP-2, MMP-9) and inflammatory cytokines (IL-6, TNF-alpha) to evaluate the therapeutic efficacy of drugs in preventing aortic rupture.
Regulatory-Grade Data Package (OECD GLP, AAALAC, CMA, CNAS):
As an established preclinical CRO, all cardiovascular studies at HuaTeng Biotechnology are conducted under stringent global quality guidelines. Our team delivers highly reproducible aortic injury profiles, providing comprehensive, auditable data packages designed to withstand rigorous regulatory audits for global IND and medical device registrants.