distal entry tears of aortic dissection
Conditions
Interventions
Interventional group:Sealing distal entry tears of aortic dissection using coil-stent system manufactured by Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd.
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Non-pregnant subjects aged 18 to 85 years old; Patients diagnosed with distal aortic dissection requiring endovascular treatment (the proximal tear of the aortic dissection has been treated, but there is still a dissection tear in the distal descending thoracic aorta and beyond and accompanied by any one or more of the following conditions: patients with distal dissection on the verge of rupture, poor perfusion of branch arteries, dissection-related pain, the maximum diameter of the aorta in the area affected by dissection >50mm, or patients with continued expansion of the dissection false lumen during follow-up)); Subjects judged by the investigator to be suitable for endovascular treatment; Subjects who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to follow up; Anatomical conditions: the diameter of the thoracoabdominal aorta is =14mm and =32mm; the number of distal tears is greater than or equal to 2, and the diameter of the tears is =20mm.
Exclusion criteria
Exclusion criteria: Women who are pregnant or breastfeeding; The patient was clearly diagnosed with aorta-related connective tissue disease (such as Marfan syndrome, etc.); The patient has a clear history of allergies to nickel-titanium alloy, platinum-tungsten alloy, contrast media, etc.; Severe liver function abnormalities (alanine aminotransferase or aspartate aminotransferase 2.5 times higher than the upper limit of normal); Hematological abnormalities: leukopenia (WBC<3×10^9/L), acute anemia (Hb<90g/L), thrombocytopenia (PLT<50×10^9/L), history of bleeding or coagulation disorder; Myocardial infarction or stroke in the past month; Cardiac function class IV (NYHA classification); Uncontrolled infection, such as bacteremia or toxemia; Patients who have malignant tumors with life expectancy less than 12 months; The subject is participating in other clinical trials of drugs or medical devices and has not yet completed the primary endpoint of the study; Patients with poor compliance and unable to follow up as planned; Other situations determined by the investigator to be inappropriate for endovascular treatment, such as the lack of suitable vascular access or the inability of the subject to cooperate, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of 30-day major adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| instant technical success rate;instant surgical success rate;clinical success rate(6-month,12-month);Aortic false lumen thrombosis(30-day, 6-month, 12-month);all-cause mortality;aortic dissection-related mortality;incidence of neurological complication;incidence of secondary intervention;aortic dissection maximum diameter and maximum diameter changes;incidence of major adverse event(6-month, 12-month); | — |
Countries
China
Contacts
Public ContactLu Qingsheng
Department of Vascular Surgery, Shanghai Changhai Hospital
Outcome results
None listed