Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.
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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: NCT05054985, who can take part
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
- NCT05054985
- Record updated
- 22 June 2025
- Original description
Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.Read full original descriptionShow less
Guo's Renovisceral Artery Reconstruction-1: a Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study)
Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.
Inclusion: 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.
Exclusion: Undergone major surgical or interventionic surgery within 30 days before surgery; Patients whose systemic or local infection may increase the risk of intravascular graft infection; 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; Severe pulmonary insufficiency who cannot tolerate general anaesthesia; 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; Serious vital organ dysfunction or other serious disease; Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L; Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms; Thoracoabdominal aortic dissection; Mycotic or infectious thoracoabdominal aortic aneurysm; 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; Severe coagulation dysfunction; takayasu arteritis; 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.