Evaluation of the Thoraflex™ Hybrid Device for Use in the Repair or Replacement of the Ascending Aorta, Aortic Arch and Descending Aorta in an Open Surgical Procedure.
The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of ascending aorta. The study will also assess safety and early clinical outcomes in patients who receive an extension procedure within 1 year of Thoraflex™ Hybrid Device implantation. Lastly the study will assess the safety and clinical outcomes of patients who receive a Thoraflex™ Hybrid Device for treatment of a ruptured aorta. Patients will be followed for 3 years. The Primary Endpoint will be freedom from defined Major Adverse Events (MAE) occurring ≤ 1 year post-procedure.
⁃ Main Study Group (All patients except Aortic Rupture Patients)
• Patient is aged 18 years or over on date of consent
• Patient is willing and able to comply with all study procedures and study visits
• Patient or their legally authorized representative has given written informed consent to participate in study
• Patient satisfies the inclusion criteria for one of the following categories:
⁃ A - Patient has acute dissection of the aorta or B - Patient has chronic dissection of the aorta or C - Patient has an aortic aneurysm (including connective tissue disorders)
⁃ A. - Patients with acute dissection of the aorta:
⁃ •Patient has acute aortic dissection and requires repair or replacement of damaged or diseased vessels of the aortic arch (with or without involvement of the ascending aorta), and the descending aorta requires replacement, or, in the opinion of the investigator, the patient would derive clinical benefit from prophylactic treatment of the descending aorta.
⁃ B. - Patients with chronic dissection of the aorta:
⁃ •Patient requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta due to chronic dissection.
⁃ And patient satisfies one or more of the following criteria:
• Patient has aortic sinus, or ascending aorta, or aortic arch, or descending aorta diameter ≥5.5cm (including if asymptomatic) or
• Patient has aorta diameter \<5.5cm and growth rate ≥0.5cm/year (including if asymptomatic) or
• Patient has ascending aorta diameter ≥4.5cm and requires valve repair or replacement
⁃ C. - Patients with an aortic aneurysm (including connective tissue disorders):
⁃ •Patient requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta
⁃ And patient satisfies one or more of the following criteria:
• Patient has aortic sinus, or ascending aorta, or aortic arch, or descending aorta diameter ≥5.5cm (including if asymptomatic) or
• Patient has aorta diameter \<5.5cm and growth rate ≥0.5cm/year(including if asymptomatic) or
• Patient has ascending aorta diameter ≥4.5cm and requires valve repair or replacement or
• Patient has Marfan syndrome or other genetically mediated disorders with aortic sinus, or ascending aorta, or arch diameter ≥4.5cm, or, the ratio of the maximal ascending or aortic root area (Π r2) in cm2 divided by the patient's height in meters exceeds 10
• Patient is aged 18 years or over, on date of consent
• Patient or their legally authorized representative is able and willing to give consent to the patient's enrolment in the study
• Patient has either a ruptured thoracic aorta, or, in the experience of the treating surgeon, is at high risk of imminent rupture of the thoracic aorta