Phase
Condition
Chest Pain
Cardiovascular Disease
Aneurysm
Treatment
Thoracoabdominal aortic stent system
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients aged greater than 18 years old and less than 80 years old;
Patients diagnosed with thoraco-abdominal aortic dissecting aneurysm and at leastone of the following conditions should be met: a)Maximum aneurysm diameter >50 mm; b)Increase in diameter by more than 5 mm inrecent 6 months c)Symptoms such as abdominal pain and back pain associated withthoracic and abdominal aortic dissecting aneurysm were identified. d)Poor morphology of thoracic and abdominal aortic dissecting aneurysm; e)Aorticdissection tears to iliac artery resulting in common iliac artery dissection tumordiameter >40 mm;
Anatomic criteria a)The diameter of the proximal anchoring area (aorta or implanted graft) ranged from 17
36 mm to ≥25 mm in length; b)Distal anchoring area (aorta or implanted graft): Ifdistal anchoring area is in iliac artery, anchoring area diameter range 725 mm,length ≥15 mm; If the distal anchoring area is in the abdominal aorta, the anchoringarea has a diameter of 1236 mm and a length of ≥20 mm; c)There is a normalanchoring area at the distal end of the visceral branch vessel. The diameter rangeof the anchoring area is 613 mm and the length is ≥15 mm. d)Normal anchoring zone at distal renal artery, anchoring zone diameter 4.5~9 mm,length ≥15 mm; e)Suitable iliac, femoral, and upper limb arterial access.Patients who understand the purpose of the trial, volunteer to participate and signthe informed consent form, and are willing to complete follow-up as required by theprotocol;
Exclusion
Exclusion Criteria:
Patients with severe hematoma in aortic wall in proximal anchoring area of stent
Patients requiring simultaneous coverage and embolization of bilateral internaliliac arteries;
Patients with a history of acute coronary syndrome within 6 months; Acute coronarysyndromes are cardiac acute ischemic syndromes resulting from rupture of an unstableatherosclerotic plaque in the coronary artery or erosion secondary to the formationof new blood 4 thrombus, including ST-elevation myocardial infarction,non-ST-elevation myocardial infarction, and unstable angina.
Patients with a transient ischemic attack (TIA) or ischemic/hemorrhagic strokewithin 3 months;
Patients with preoperative hepatic and renal dysfunction [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the normal upper limit; Serumcreatinine (Cr) >150u mol/L];
Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;
Patients with severe coagulopathy;
Patients with a history of hypersensitivity to contrast agents, anticoagulants,antiplatelet agents, stent delivery devices (i.e., nitinol, polyester, PTFE, nylonpolymer materials);
Patients with connective tissue diseases such as systemic lupus erythematosus,Marfan syndrome, Egyptian syndrome, or Behcet's disease;
Patients with arteritis;
Patients with significant organ dysfunction or other serious disease;
Women with planned pregnancy, pregnancy stage , or lactation;
The patient participated in another clinical trial and was not out or withdrawnwithin the first 3 months of the screening period of this trial.
Patients with a life expectancy of not more than 1 year;
Patients judged by the investigator to be unsuitable for endovascular treatment;
Study Design
Study Description
Connect with a study center
Chinese PLA General Hospita
Beijing, Beijing
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.