Aortic arch dissection lesion
Conditions
Interventions
Sponsors
Fudan University Affiliated Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years of age; 2. Diagnosis and Anatomical Suitability: Subacute or chronic aortic arch dissection requiring intervention, where the proximal end of the stent graft requires anchoring in Zone 0, and meets the following vascular anatomical criteria: (1) Ascending aorta (may include graft segments) >= 40 mm in length (measured from the sinotubular junction to the proximal edge of the IA along the centerline); (2) Proximal landing zone diameter >= 24 mm and = 20 mm; (4) Diameters of the IA, LCCA, and LSA = 6 mm, with lengths >= 20 mm; (5) Suitable arterial access for endovascular intervention; 3. Informed Consent: Capable of understanding the study purpose, voluntarily agreeing to participate, and providing written informed consent (by the subject or their legal representative). Willing to comply with follow-up requirements per the protocol; 4. Surgical Risk Assessment: Deemed high surgical risk (evaluated by at least two independent vascular or cardiac surgeons) or confirmed to have significant contraindications to open surgery.
Exclusion criteria
Exclusion criteria: 1. Prior aortic intervention: History of open or endovascular repair of the descending or abdominal aorta; 2. Concurrent AAA requiring intervention: Coexisting abdominal aortic aneurysm requiring surgical intervention within 30 days; 3. Specific aortic pathologies: infectious aortitis, Takayasu arteritis, Marfan syndrome, or other connective tissue disorders; 4. Active systemic infection: Ongoing systemic infection or high risk of systemic infection; 5. Severe arch vessel disease: Severe stenosis, calcification, thrombosis, or tortuosity of the IA, LCCA, or LSA; 6. Acute ischemia: Bowel necrosis or lower limb ischemic necrosis; 7. Pre-existing paraplegia; 8. Post-cardiac transplant status; 9. Recent cardiovascular events: Myocardial infarction or stroke within the past 3 months; 10. Advanced heart failure: NYHA Class IV or left ventricular ejection fraction (LVEF) 221 µmol/L (2.5 mg/dL) or end-stage renal disease requiring dialysis (investigator discretion); 14. Severe hepatic dysfunction: ALT/AST > 5× upper limit of normal (ULN), Serum total bilirubin (STB) > 2× ULN; 15. High-risk intracranial lesions (any of the following): (1) Unruptured aneurysm >=7 mm (anterior circulation) or >=5 mm (posterior circulation); (2) Prior rupture or high-risk morphology (daughter sac, aspect ratio >1.6); (3) Intracranial arterial stenosis >=50% with poor collateral flow; 16. Contrast allergy; 17. Pregnancy or lactation; 18. Anesthesia/surgery contraindications: Severe comorbidities precluding tolerance to anesthesia or surgery; 19. Life expectancy < 12 months; 20. Current participation in other drug or device clinical trials; 21. Other exclusions: Any conditions deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day major adverse event (MAE)-free rate;12-month Clinical Treatment Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Aortic dissection vascular remodeling success rate;Type I or III endoleak incidence rate;Aortic and branch stent graft migration rate;Postoperative branch vessel occlusion rate;Secondary surgical intervention rate; | — |
Countries
China
Contacts
Public ContactFu Weiguo
Fudan University Affiliated Zhongshan Hospital
Outcome results
None listed