Evaluating a new stent graft system for treating thoracoabdominal aortic aneurysms

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)

This study tests a new type of stent graft to see if it safely helps people with thoracoabdominal aortic aneurysms.

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, Beijing Municipality)
• Trial ID: NCT05054985 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a multi-branched thoracoabdominal stent graft system specifically designed for patients with thoracoabdominal aortic aneurysms. Eligible participants, aged 18 to 80, will undergo implantation of the stent graft after meeting specific anatomical and diagnostic criteria. Following the procedure, patients will be monitored at discharge, and at 1, 6, and 12 months to assess outcomes and any potential complications.

Who should consider this trial

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

Not a fit: Patients with thoracoabdominal aortic aneurysms that do not meet the inclusion criteria or have significant comorbidities 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 the risk of complications associated with traditional surgical methods.

How similar studies have performed: Other studies have shown promise with similar stent graft approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. 18 years old ≤ age ≤ 80 years old;
2. 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;

   1. Maximum diameter of thoracoabdominal aortic aneurysm\>50mm;
   2. The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;
3. anatomical criteria

   1. The proximal anchoring region (aorta or implanted graft) was 17\~36 mm in diameter and ≥25 mm in length;
   2. 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;
   3. The diameter of the vessel anchoring area of the visceral branch ranges from 6\~13 mm and the length ≥15 mm;
   4. The diameter of renal artery anchoring area ranges from 4.5\~9mm, and the length ≥15 mm;
   5. Appropriate iliac, femoral and upper limb artery access;
4. 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 Criteria:

1. Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;
2. Thoracoabdominal aortic dissection;
3. Mycotic or infectious thoracoabdominal aortic aneurysm;
4. Patients whose systemic or local infection may increase the risk of intravascular graft infection;
5. Superior mesenteric, celiac, or renal artery occlusion;
6. Requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
7. 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;
8. 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.
9. Transient ischemic attack (TIA) or ischemic/haemorrhagic 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. A history of allergy to contrast agents, anticoagulants, antiplatelet drugs, stents, and conveyor materials (nitinol, polyester, PTFE, nylon);
15. Connective tissue diseases such as systemic lupus erythematosus, Marfan's syndrome, Adam's syndrome, or Behcet's disease;
16. takayasu arteritis;
17. Serious vital organ dysfunction or other serious disease;
18. Planning pregnancy, pregnancy, or breastfeeding;
19. 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.
20. Life expectancy less than 1 year;
21. Patients who, in the judgment of the investigator, are not eligible for endotherapy.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

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

Conditions: Thoracoabdominal Aortic Aneurysms, Guo's Visceral Arteries Reconstruction, Multi-branched Thoracoabdominal Stent Graft System, Thoracoabdominal Aortic Aneurysm