Eligibility Details:
Inclusion Criteria:
- 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 authorised representative (LAR) has given written informed
consent to participate in study. For emergency patients only, retrospective consent is
permissible
- Patient satisfies the inclusion criteria for one of the following categories:
A - Patient has acute thoracic aortic syndrome or B - Patient has subacute/ chronic
dissection of the aorta or C - Patient has an aortic aneurysm (including connective tissue
disorders)
A. Patients with acute thoracic aortic syndrome:
Patient has acute thoracic aortic syndrome 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.
This includes patients with acute dissections, rupture of the aorta or PAU.
B. Patients with subacute/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
subacute/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 (Î r2) in cm2 divided by the patient's height in meters exceeds 10
Exclusion Criteria:
- Patient is unfit for open surgical repair involving circulatory arrest
- Patient has known sensitivity to polyester, nitinol or materials of bovine origin
- Patient has active endocarditis or an active infective disorder of the aorta
- Patient has an active systemic infection that, in the opinion of the investigator,
would compromise the outcome of the surgical procedure
- Patient is enrolled in another active study and has received an investigational
product (device, pharmaceutical or biologic) within 6 months prior to the date of the
implant or has not reached the primary endpoint of the study, which in the opinion of
the Investigator will impact on this study
- Patient has an uncorrectable bleeding anomaly
- Patient has renal failure (defined as dialysis dependent)
- Patient has known sensitivity to radiopaque contrast agents that cannot be adequately
pre-treated
- Patient has a co-morbidity causing expected survival to be less than 1 year
- Patient has any other medical, social or psychological problems that in the opinion of
the investigator preclude them from receiving this treatment and the procedures and
evaluations pre and post procedure
common.study.methods.has-drugs-no
common.study.methods.is-healthy-yes
