Standford Type B aortic dissection
Conditions
Interventions
Experimental Group:Thoracic Aortic Stent Graft System
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-80 years old who are non-pregnant or non-lactating; 2. Patients diagnosed with Stanford type B aortic dissection, with a time from onset to surgery =15mm and proximal anchoring zone aortic diameter of 19-43mm; 4. Patients deemed suitable for endovascular treatment as assessed by the investigator; 5. Able to comprehend the trial objectives, voluntarily participate in the study, with the subject or their legal representative signing the informed consent form, and willing to complete follow-ups as per protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Absence of suitable arterial access; 2. Severe stenosis or calcification in the proximal anchoring zone that may hinder proper stent apposition; 3. Structural aortic wall abnormalities due to hereditary connective tissue disorders (e.g., Marfan syndrome, Loeys-Dietz syndrome); 4. History of aortic injury requiring vascular repair procedures (e.g., artificial graft replacement, aortic stent implantation); 5. Patients requiring intraoperative use of chimney technique, graft fenestration technique, or supra-arch branched stent technology; 6. Hemorrhagic disorders or uncorrectable coagulation dysfunction; 7. Allergy to contrast agents, nitinol (nickel-titanium alloy), or other stent materials; 8. Severe hepatic or renal dysfunction: ALT/AST >2.5× upper limit of normal (ULN) or serum creatinine >2× ULN; 9. Patients with acute abdomen or intestinal necrosis; 10. Uncontrolled infections (e.g., bacteremia, sepsis); 11. Myocardial infarction or stroke within 3 months prior to enrollment; 12. Severe comorbidities with life expectancy <12 months; 13. Concurrent participation in other drug/device clinical trials without completing primary endpoints; 14. Other conditions deemed unsuitable for trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate for aortic dissection;30-Day Postoperative Major Adverse Event (MAE) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Immediate Technical Success Rate;endoleak incidence rate;Aortic Diameter;False Lumen Thrombosis Rate;Aortic Remodeling Rate;Secondary Intervention Rate;Adverse Event Rate;Device-Related Adverse Event Rate;Major Adverse Event (MAE) Rate;All-Cause Mortality Rate;Aortic Dissection-Related Mortality Rate;Neurological Complication Rate;Visceral Ischemic Complication Rate; | — |
Countries
CHINA
Contacts
Public ContactXiangchen DAI
Tianjin Medical University General Hospital
Outcome results
None listed