Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05803564, who can take part
Where in China
- Chinese PLA General HospitaBeijing, ChinaContact: Wei GuoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Trial code
- NCT05803564
- Record updated
- 22 June 2025
- Original description
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.Read full original descriptionShow less
Clinical Application of a New Technique of Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.
Inclusion: Patients aged greater than 18 years old and less than 80 years old; Patients diagnosed with thoraco-abdominal aortic dissecting aneurysm and at least one of the following conditions should be met:; a)Maximum aneurysm diameter >50 mm; b）Increase in diameter by more than 5 mm in recent 6 months c）Symptoms such as abdominal pain and back pain associated with thoracic and abdominal aortic dissecting aneurysm were identified; d）Poor morphology of thoracic and abdominal aortic dissecting aneurysm; e）Aortic dissection tears to iliac artery resulting in common iliac artery dissection tumor diameter >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): If distal anchoring area is in iliac artery, anchoring area diameter range 7~25 mm, length ≥15 mm; If the distal anchoring area is in the abdominal aorta, the anchoring area has a diameter of 12~36 mm and a length of ≥20 mm; c）There is a normal anchoring area at the distal end of the visceral branch vessel. The diameter range of the anchoring area is 6~13 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 sign the informed consent form, and are willing to complete follow-up as required by the protocol.
Exclusion: Patients with a history of acute coronary syndrome within 6 months; Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture of an unstable atherosclerotic plaque in the coronary artery or erosion secondary to the formation of 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 stroke within 3 months; Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia; Patients with a history of hypersensitivity to contrast agents, anticoagulants, antiplatelet agents, stent delivery devices (i.e., nitinol, polyester, PTFE, nylon polymer materials); Patients with connective tissue diseases such as systemic lupus erythematosus, Marfan syndrome, Egyptian syndrome, or Behcet's disease; Patients with significant organ dysfunction or other serious disease; Patients with preoperative hepatic and renal dysfunction [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the normal upper limit; Serum creatinine (Cr) >150u mol/L]; Patients with severe hematoma in aortic wall in proximal anchoring area of stent; Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries; Patients with severe coagulopathy; Patients with arteritis; Women with planned pregnancy, pregnancy stage , or lactation; The patient participated in another clinical trial and was not out or withdrawn within 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.