Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.

Launched by LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. · Mar 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for a serious condition called thoracoabdominal aortic dissecting aneurysm, which involves a tear in the main artery that runs from the heart down through the chest and abdomen. The researchers are testing a special stent system, a type of device that can be placed inside the artery to help repair it without the need for open surgery. This is the first time this specific stent system is being tested in people, and the goal is to see if it is safe and effective for treating this condition.

To participate in this trial, patients need to be between 18 and 80 years old and diagnosed with thoracoabdominal aortic dissecting aneurysm that meets certain conditions, such as having a large aneurysm or experiencing specific symptoms. Participants will receive the new treatment and will be monitored closely to evaluate how well it works and to ensure their safety. It's important for potential participants to understand the trial's purpose and agree to follow-up visits as needed. Overall, this study aims to provide new options for patients facing this complex health issue.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged greater than 18 years old and less than 80 years old;
• 2. 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;
• • 3. 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.
• • 4. 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 Criteria:
• • 1. Patients with severe hematoma in aortic wall in proximal anchoring area of stent
• • 2. Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
• • 3. 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.
• • 4. Patients with a transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within 3 months;
• • 5. Patients with preoperative hepatic and renal dysfunction \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the normal upper limit; Serum creatinine (Cr) \>150u mol/L\];
• • 6. Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;
• • 7. Patients with severe coagulopathy;
• • 8. Patients with a history of hypersensitivity to contrast agents, anticoagulants, antiplatelet agents, stent delivery devices (i.e., nitinol, polyester, PTFE, nylon polymer materials);
• • 9. Patients with connective tissue diseases such as systemic lupus erythematosus, Marfan syndrome, Egyptian syndrome, or Behcet's disease;
• • 10. Patients with arteritis;
• • 11. Patients with significant organ dysfunction or other serious disease;
• • 12. Women with planned pregnancy, pregnancy stage , or lactation;
• • 13. 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.
• • 14. Patients with a life expectancy of not more than 1 year;
• • 15. Patients judged by the investigator to be unsuitable for endovascular treatment;