Stanford Type Aortic Dissection
Conditions
Interventions
Case series:Implant FDMS stent
Sponsors
1st Affiliated Hospital of PLA Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
15 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients judged by clinical investigators as high-risk patients for surgery (EuroScore score >=6 points); or patients judged by the investigators to be unsuitable for surgery; and those who need to meet any of the following: (1) The dissection does not involve the aortic root sinus; (2) The aortic root sinus is involved, after surgery; the arch is still involved in the dissection; (3) Aortic arch replacement is required; 2. Definite diagnosis of type A aortic dissection and continuous involvement of the aortic arch or at least one main branch artery (innominate artery, left common carotid artery, left subclavian artery); 3. Patients can understand the purpose of the trial, volunteer to participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients without suitable vascular access; 2. The patient has a clear history of allergy to nickel-titanium alloy materials; 3. Patients with liver and kidney dysfunction (creatinine is greater than 2.5 times the upper limit of normal; ALT and AST are greater than 2.5 times the upper limit of normal (ULN)); 4. Patients who cannot follow up on time; 5. The lesion of the aorta has ruptured; 6. Myocardial infarction or cerebrovascular accident occurred within 30 days before implantation; 7. Patients who have or are suspected of suffering from connective tissue degenerative disease, or have related family history; 8. Medical contraindications for local or general anesthesia; 9. Patients who are known to be contraindicated with anticoagulants, antiplatelet agents or contrast agents; 10. Those who have been or may be allergic to aspirin, clopidogrel, heparin, contrast agents, polylactic acid polymers and rapamycin; 11. Patients undergoing chemotherapy or planning to receive chemotherapy; 12. History of bleeding disorders or coagulopathy; 13. Aortic fluffy syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| in Hospital major complication rate(including death); | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate postoperative technical success rate;30 days postoperative No aortic rupture ;30 days postoperative aortic remodelling;30 days postoperative branch patency;30 days postoperative device migration;30 days postoperative transfer to surgery;12 M post operative Treatment Success Rate;12M postoperative No Aortic Rupture;12M postoperative Aortic Remodelling;12M postoperative Branch Patency;12M postoperative device migration;12M postoperative transfer to surgery;30d postoperative all-cause mortality;30D post operative Treatment Success Rate;30D post operative aortic dessection related rupture;30D post operative AE;30D post operative MAE;30D post operative SAE;Lab test; | — |
Countries
China
Contacts
Public ContactProf.Liu Jincheng
Cardiothoracic Surgery Department of 1st Affiliated Hospital of PLA Air Force Military Medical University
Outcome results
None listed