Using a multibranched stent graft to treat thoracoabdominal aortic aneurysms

GUo's Renovisceral Artery Reconstruction-2: a Prospective,Single Center,Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a multibRANched sTEnt Graft systEm for Thoracoabdominal Aortic Aneurysm

This study is testing a new type of stent graft to see if it can safely and effectively treat thoracoabdominal aortic aneurysms in patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 73 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. (industry)
• Locations: 1 site (Beijing)
• Trial ID: NCT06478576 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of a multibranched stent graft system for the endovascular treatment of thoracoabdominal aortic aneurysms (TAAA). The protocol requires strict adherence by physicians, with provisions for emergency deviations if necessary. Patients will be monitored closely to assess the effectiveness and safety of the intervention, following established guidelines for TAAA treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with thoracoabdominal aortic aneurysms that meet specific anatomical and clinical criteria.

Not a fit: Patients with smaller aneurysms or those who do not meet the anatomical criteria for the stent graft may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with thoracoabdominal aortic aneurysms, potentially reducing recovery time and complications.

How similar studies have performed: Previous studies on endovascular treatments for aortic aneurysms have shown promising results, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 and ≤80 years;
2. Patients diagnosed with thoracoabdominal aortic aneurysm (based on the modified Crawford classification and the 2019 European guidelines for the treatment of aortic aneurysms), and should meet at least one of the following conditions:

   1. Maximum diameter of TAAA \>50 mm,
   2. Rapid growth of sac \>5 mm in diameter in the most recent 6 months, or rapid growth \>10 mm in diameter within 1 year
   3. Symptoms related to thoracoabdominal aortic aneurysm, such as clear abdominal pain and back pain.
3. Anatomical criteria, including:

   1. Proximal landing zone 17-36 mm in diameter and ≥25 mm in length
   2. If distal landing zone in abdominal aorta:Distal landing zone 12-36 mm in diameter and ≥20 mm in length If distal landing zone in iliac artery:Distal landing zone 7-25 mm in diameter and ≥15 mm in length
   3. Visceral vessel landing zone 6-13 mm in diameter and ≥15 mm in length
   4. Renal artery landing zone 4.5-9 mm in diameter and ≥15 mm in length
4. Patients with Feasible iliofemoral artery and upper patent upper extremity access;
5. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the requirements of the protocol;

Exclusion Criteria:

1. Ruptured aortic aneurysm in unstable haemodynamic condition;
2. Aneurysmal aortic dissection;
3. Infected or mycotic aortic aneurysm;
4. Patients whose systemic or local infection may increase the risk of intravascular graft infection;
5. Patients with occlusion of the superior mesenteric artery, celiac trunk, or renal artery.
6. Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
7. Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
8. Diagnosis of acute coronary syndrome within 6 months; Acute coronary syndrome refers to an acute cardiac ischemia syndrome caused by the rupture or erosion of unstable atherosclerotic plaques in the coronary arteries, which is followed by the formation of fresh thrombus. It includes ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.
9. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
10. Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L;
11. Severe pulmonary insufficiency who cannot tolerate general anaesthesia;
12. Severe coagulation dysfunction;
13. Undergone major surgical or interventionic surgery within 30 days before surgery;
14. An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system( (referring to nickel-titanium, polyester, PTFE, nylon-based polymer materials);
15. Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;
16. Patients with takayasu arteritis;
17. Patients with serious vital organ dysfunction or other serious disease;
18. Planning pregnancy, pregnancy, or breastfeeding;
19. The patient participated in other clinical trials or not completed or withdrawn from other clinical trials within the last 3 months at the time of screening period ;
20. Life expectancy less than 1 year;
21. Patients who are not appropriate for endovascular repair based on the investigators' clinical judgement.

Where this trial is running

Beijing

• Chinese PLA General Hospital — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Wei Guo, Professor — Chinese PLA General Hospital
• Study coordinator: Wei Xu, PM

Conditions: Thoracoabdominal Aortic Aneurysm, Lifetech, multibranched stent graft system, Endovascular Treatment