Total Endovascular Aortic Arch Re-construction Study(TEARS)

Study Overview
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Brief Summary
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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/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.

Detailed Description
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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 arrest (DHCA). Despite increasing experience and refinement of these procedures, there remains a substantial rate of morality and morbidity. Total endovascular aortic arch and ascending aorta repair is one of the ultimate solutions of these diseases. However, this approach requires extensive technique and new device development. The goal of total endoluminal stent grafting is to re-construct the ascending aorta and aortic arch to cover the primary entry tear of the dissection and to remodel the aorta.Recently, branch and fenestrated stent-grafts has been developed to treat complex ascending and aortic arch disease, which was previously considered to be contraindicated for endovascular repair. This study aims 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/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al. Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study designs to enroll 50 patients to be monitored for 24 months.

Official Title
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Total Endovascular Aortic Arch Re-construction Study(TEARS)------China's Registry

Conditions
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Aorta Dissection, Aorta Aneurysm

Intervention / Treatment
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* Device: Ankura Branched/Fenestrated Stent Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular<br>Total endovascular arch reconstruction | Device: Ankura Branched/Fenestrated Stent Graft<br>* Ankura Branched/Fenestrated Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）<br>* Other names: Ankura Fenestrated Stent Graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative MACE (including death, rupture, paraplegia, aneurysm formation) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoleak | Endoleak of all types | 12 months | 
| Stent-graft migration/kinking | Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention | 12 months | 
| cumulative cerebrovascular events | cumulative cerebrovascular events | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Diseases, Vascular Diseases, Cardiovascular Diseases, Treatment Outcome, Aorta Dissection, Aorta Aneurysm, Aorta pseudoaneurysm, Endovascular aortic repair