Status:
UNKNOWN
Total Endovascular Aortic Arch Re-construction Study(TEARS)
Lead Sponsor:
Xijing Hospital
Conditions:
Aorta Dissection
Aorta Aneurysm
Eligibility:
All Genders
12-90 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the short to mid term efficacy and safety of a newly-developed branched stent graft in patients who had complex aortic lesions, such as ascending aortic/arc...
Detailed Description
Aneurysms and dissection involving the ascending aorta and aortic arch have historically been treated with open surgical techniques, requiring cardiopulmonary bypass and deep hypothermic circulatory a...
Eligibility Criteria
Inclusion
- Ascending aortic/arch aneurysm
- Ascending aortic/arch pseudo-aneurysm
- Stanford Type A dissection
- Retrograde Stanford Type B dissection
- Unclassified dissection with primary tear located in the aortic arch
- Able to tolerate endotracheal intubation and general anesthesia
- Subject's anatomy must meet the anatomical criteria to receive that implanted device
- The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
- Availability for the appropriate follow-up visits during the follow-up period
- Capability to follow all study requirements
Exclusion
- ASA classification = V
- Severe renal insufficiency defined as SVS risk renal status = 3
- Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
- Presence of connective tissue disease
- Active infection or active vasculitides
- Pregnant woman or positive pregnancy test
- Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
- Subject has had a cerebral vascular accident (CVA) within 2 months.
- History of drug abuse
- Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
- Subject has a known allergy or intolerance to the device components.
- Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
- Subject has a co-morbidity causing expected survival to be less than 1 year.
- Enrolment in another clinical study
- Unwillingness to cooperate with study procedures or follow-up visits
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01496833
Start Date
January 1 2015
End Date
December 1 2018
Last Update
January 1 2016
Active Locations (1)
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1
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032