Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

Recruiting now · Not applicable

Conditions studied: Thoracoabdominal Aortic Aneurysms

In brief

Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.

Key facts

Study ID

NCT05054985

Run by

Lifetech Scientific (Shenzhen) Co., Ltd.

People needed

73

Starts

2021-11-12

Expected to finish

2028-12-31

Last updated by the study team

2025-06-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years old ≤ age ≤ 80 years old;
• Diagnosed as thoracoabdominal aortic aneurysm (based on modified Crawford classification and 2019 European Guidelines for the Treatment of Aortic aneurysm) and should meet at least one of the following conditions;
• Maximum diameter of thoracoabdominal aortic aneurysm>50mm;
• The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;
• anatomical criteria
• The proximal anchoring region (aorta or implanted graft) was 17\~36 mm in diameter and ≥25 mm in length;
• Distal anchoring region (aorta or implanted graft): If the distal anchoring region is in the iliac artery, the anchoring region has a diameter range of 7\~25 mm and a length of ≥15 mm; If the distal anchoring area is in the abdominal aorta, the diameter of the anchoring area ranges from 12\~36mm and the length≥ 20mm;
• The diameter of the vessel anchoring area of the visceral branch ranges from 6\~13 mm and the length ≥15 mm;
• The diameter of renal artery anchoring area ranges from 4.5\~9mm, and the length ≥15 mm;
• Appropriate iliac, femoral and upper limb artery access;
• Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;

You may not qualify if…

• Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;
• Thoracoabdominal aortic dissection;
• Mycotic or infectious thoracoabdominal aortic aneurysm;
• Patients whose systemic or local infection may increase the risk of intravascular graft infection;
• Superior mesenteric, celiac, or renal artery occlusion;
• Requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
• Severe stenosis, calcification, or mural thrombus in the anchoring area of the stent tend to have difficulty in attachment of the stent-graft or affect the patency of the stent;
• A history of acute coronary syndrome within 6 months; Acute coronary syndrome is defined as an acute ischemic syndrome of the heart resulting from the rupture or erosion of unstable intracoronary atherosclerotic plaques followed by fresh thrombosis, including ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.
• Transient ischemic attack (TIA) or ischemic/haemorrhagic stroke within 3 months;
• Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L;
• Severe pulmonary insufficiency who cannot tolerate general anaesthesia;
• Severe coagulation dysfunction;
• Undergone major surgical or interventionic surgery within 30 days before surgery;
• A history of allergy to contrast agents, anticoagulants, antiplatelet drugs, stents, and conveyor materials (nitinol, polyester, PTFE, nylon);
• Connective tissue diseases such as systemic lupus erythematosus, Marfan's syndrome, Adam's syndrome, or Behcet's disease;
• takayasu arteritis;
• Serious vital organ dysfunction or other serious disease;
• Planning pregnancy, pregnancy, or breastfeeding;
• Patients who participated in other clinical trials and was not discontinued or withdrawn within the first 3 months of the screening period of this trial.
• Life expectancy less than 1 year;
• Patients who, in the judgment of the investigator, are not eligible for endotherapy.

Where it is running

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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