Thoraflex Hybrid Post-Market Study (NCT03414866) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Thoraflex Hybrid Post-Market Study
Canada, Germany182 participantsStarted 2018-05-25
Plain-language summary
This is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic aneurysm.
Who can participate
Age range18 Years
SexALL
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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 descendin…