Badanie kliniczne: Type B Aortic Dissection

Kryteria wyłączenia kto nie może wziąć udziału (30)

1. General Exclusion Criteria:
2. Age < 18 years
3. Pregnant, breast-feeding or planning on becoming pregnant during the entire duration of the study
4. Unable to provide written informed consent
5. Unable or unwilling to comply with the requirements of the study protocol
6. Taking part already in an investigational device or drug study that could interfere with the outcomes being studied
7. Active drug addiction or known history of drug abuse within one year of treatment
8. Medical Exclusion Criteria:
9. Aortic rupture (free or contained including haemothorax, increasing periaortic hematoma, or mediastinal hematoma)
10. Aortic fistula
11. Suspicion of bowel necrosis or irreversible visceral ischemia
12. Stage 5 chronic kidney disease
13. Life expectancy of less than 2 years due to any other medical condition than the dissection to be treated
14. Active malignancy
15. Known sensitivities or allergies to the device materials (including cobalt, chromium, nickel)
16. Known sensitivities or allergies to contrast materials that cannot be pre-medicated
17. Mycotic aortic aneurysm or active systemic infection that may place the patient at increased risk of endovascular infection
18. American Society of Anaesthesiologists (ASA) class V (moribund patient not expected to live 24 hours with or without operation)
19. Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's, Loeys-Dietz or Ehlers-Danlos syndrome)
20. Uncorrectable coagulopathy, bleeding diathesis or refusal of blood transfusion
21. Any major cardiovascular or cerebrovascular ischemic event, including myocardial infarction or stroke, or treatment of such event, within 90 days prior to enrolment
22. Any aortic-related interventional or surgical procedure within 30 days prior to enrolment
23. Any planned aortic-related interventional or surgical procedure within 30 days after the study procedure
24. Anatomical Exclusion Criteria:
25. Aneurysmal dilatation of the false lumen defined as maximum transaortic diameter >55 mm in women or >60 mm in men in the thoraco-abdominal segment or >50 mm in women or >55 mm in men in the abdominal segment, measured inner-wall to inner-wall;
26. Inadequate proximal landing zone for the stent graft, such zone being <20 mm long
27. Inadequate proximal landing zone geometry for the Allay® Aortic Stent (e.g. aortic kink)
28. Planned implantation of a stent graft with a distal diameter >38 mm or <20 mm
29. Aorta or iliac anatomy not allowing the advancement of the delivery system
30. Subject in whom the thoracic stent graft is either 1) not implanted in its intended position and/or 2) leads to any serious device complication, and/or who has 3) persistent static obstruction of the visceral or both renal arteries, prior to Allay® Aortic Stent implantation, will not be implanted with the Allay® Aortic Stent and will be withdrawn from the study