Endovascular treatment for thoracoabdominal aortic dissecting aneurysm

Clinical Application of a New Technique of Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.

This study tests a new stent system to see if it helps people with thoracoabdominal aortic dissecting aneurysms feel better and stay safe after treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05803564 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a thoracoabdominal aortic stent system for patients with thoracoabdominal aortic dissecting aneurysms. Eligible patients will undergo implantation of the stent system and will be monitored for outcomes at discharge and at 1, 6, and 12 months post-procedure. The study aims to determine how well this new intervention works in managing this serious condition.

Who should consider this trial

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

Not a fit: Patients with aortic conditions not meeting the inclusion criteria or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with thoracoabdominal aortic dissecting aneurysms.

How similar studies have performed: While this approach is novel, similar endovascular techniques have shown promise in treating other types of aortic aneurysms.

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;

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospita — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

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

Conditions Thoracoabdominal; Aortic, Aneurysm, Dissecting; Thoracoabdominal aortic stent system; thoracoabdominal aortic dissecting aneurysm; G-Branch