Aortic Dissection Type B
Conditions
Keywords
aortic dissection, endovascular therapy, timing of intervention
Brief summary
This is a prospective, multicenter, non-inferior, parallel-controlled observational study. This study aims to compare clinical outcomes of endovascular treatment for acute high-risk type B aortic dissection in the acute phase versus the subacute phase. No interventions will be imposed on the patients' standard treatment. Patients with acute high-risk type B aortic dissection will be grouped based on the actual timing of their treatment.
Interventions
PROCEDUREAcute Phase
Patients with acute high-risk type B aortic dissection received endovascular treatment in acute phase (2-14days)
PROCEDURESubacute Phase
Patients with acute high-risk type B aortic dissection received endovascular treatment in subacute phase (≥14days)
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Acute (2-14 days) high-risk type B aortic dissection. * Completion of thoracoabdominal aortic CTA before enrollment. * Ability to understand the study objectives and voluntarily participate, with signed informed consent from the patient or their legal representative. * Willingness and ability to comply with follow-up visits and study protocols.
Exclusion criteria
* Acute complicated type B aortic dissection. * Traumatic dissection or penetrating aortic ulcer. * Connective tissue diseases (e.g., Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome). * Pregnancy, women of childbearing potential, or breastfeeding. * Uncontrolled active infection or active vasculitis. * Unsuitable access vessels or infection at the access site. * Endovascular repair requiring ≥2 branch reconstructions. * Prior aortic surgery (open or endovascular). * Life expectancy \<2 years. * Myocardial infarction or cerebrovascular accident within 4 weeks before enrollment. * Severe gastrointestinal bleeding, major surgery, myocardial infarction, or uncorrected coagulation dysfunction within 6 weeks before enrollment. * Other conditions deemed by the investigator to compromise the patient's medical interests or unlikely adherence to the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day all-cause mortality rate | 30 days following the operation | paraplegia, stroke, new entry tear, renal/liver dysfunction, type I/II/R endoleak |
| 30-day complication rate | 30 days following the operation | access site complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 12 months following the operation | rupture, stent-induced new entry, ischemia (renal/limb/intestinal/spinal), endoleak, dissection aneurysm, stroke, venous thrombosis, all-cause death. |
| aortic remodeling | 12 months following the operation | aortic diameter growth \> 5 mm in 12 months; dissection aneurysm |
| 5-year all-cause mortality rate | 5 years following the operation | long-term outcome |
| 5-year complication rate | 5 years following the operation | long-term outcome |
Countries
China
Outcome results
None listed