Evaluation of the Safety and Efficacy of the Multilayer Stent (STRATO)

Inclusion Criteria:

• Age >18 years
• Life expectancy ≥ 12 months
• The patient or his legal representative has signed the informed consent form
• Thoracoabdominal aneurysm type 2 or 3 with vital collaterals and requiring intervention to prevent its rupture according to the criteria defined by consensus ("Expert Consensus Document on the Treatment of Descending Thoracic Aortic Disease Using Endovascular Stent-Grafts", Ann Thorac Surg 2008;85:S1-41)

• Contraindicated for open surgery, declared inoperable by the surgeon and anesthetist (statement signed by each doctor) and must have at least one of the following:

  1. Age > 80 years
  2. ASA ≥ 3
  3. History of thoracic surgery or surgery of the abdominal aorta
  4. Coronary artery disease (history of angina or myocardial infarction) with positive functional testing and coronary lesions for which revascularization is impossible or not indicated
  5. Heart failure
  6. Inoperable aortic stenosis
  7. LVEF <40%;

  8. chronic respiratory failure defined by one of the following criteria:

     1. FEVl <1.2 l / sec;
     2. VC <50% of the predicted value according to age, sex and weight;
     3. arterial blood gas analysis in the absence of oxygen: PaCO ²> 45 mmHg or PaO ² <60 mmHg
     4. Oxygen therapy
  9. renal insufficiency if creatininaemia> 200 micromol / l before injection of contrast product;
  10. hostile abdomen, including presence of ascites or other signs of portal hypertension;
  11. obesity.
• adequate arterial anatomy of aneurismal lesion access.

Exclusion Criteria:

• medical contraindications to a local or general anesthesia and angiography;
• Life expectancy less than one year, or clinical follow-up impossible;
• congenital disorders of blood coagulation;
• intercurrent infection;
• allergy to aspirin, clopidogrel, or contrast agents;
• patient (s) included in another clinical study;
• patient pregnant or breastfeeding