Total Endovascular Aortic Arch Re-construction Study(TEARS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Aorta Dissection; Aorta Aneurysm	Device: Ankura Branched/Fenestrated Stent Graft	Not Applicable

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 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Intervention Model:	Single Group Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Total Endovascular Aortic Arch Re-construction Study(TEARS)------China's Registry
Study Start Date :	January 2015
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Endovascular; Total endovascular arch reconstruction	Device: Ankura Branched/Fenestrated Stent Graft; Ankura Branched/Fenestrated Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）; Other Names: Ankura-TM Stent Graft; Ankura Branched Stent Graft; Ankura Fenestrated Stent Graft

Outcome Measures

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Primary Outcome Measures :

1. cumulative MACE (including death, rupture, paraplegia, aneurysm formation) [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Endoleak [ Time Frame: 12 months ]
   Endoleak of all types
2. Stent-graft migration/kinking [ Time Frame: 12 months ]
   Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention
3. cumulative cerebrovascular events [ Time Frame: 12 months ]
   cumulative cerebrovascular events

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 90 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Ascending aortic/arch aneurysm
2. Ascending aortic/arch pseudo-aneurysm
3. Stanford Type A dissection
4. Retrograde Stanford Type B dissection
5. Unclassified dissection with primary tear located in the aortic arch
6. Able to tolerate endotracheal intubation and general anesthesia
7. Subject's anatomy must meet the anatomical criteria to receive that implanted device
8. The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
9. Availability for the appropriate follow-up visits during the follow-up period
10. Capability to follow all study requirements

Exclusion Criteria:

1. ASA classification = V
2. Severe renal insufficiency defined as SVS risk renal status = 3
3. Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
4. Presence of connective tissue disease
5. Active infection or active vasculitides
6. Pregnant woman or positive pregnancy test
7. Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
8. Subject has had a cerebral vascular accident (CVA) within 2 months.
9. History of drug abuse
10. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
11. Subject has a known allergy or intolerance to the device components.
12. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
13. Subject has a co-morbidity causing expected survival to be less than 1 year.
14. Enrolment in another clinical study
15. Unwillingness to cooperate with study procedures or follow-up visits

Contacts and Locations

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Contacts

Contact: Jian Yang, MD,PhD	86-13892828016	yangjian1212@hotmail.com

Locations

China, Shaanxi
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University	Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Jian Yang, MD,PhD

Sponsors and Collaborators

Xijing Hospital

Investigators

Principal Investigator:	Jian Yang, MD,PhD	Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Study Chair:	Dinghua Yi, M.D., PhD.	Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Xijing Hospital
ClinicalTrials.gov Identifier:	NCT01496833 History of Changes
Other Study ID Numbers:	XJ-20111126
First Posted:	December 21, 2011
Last Update Posted:	January 1, 2016
Last Verified:	December 2015

Keywords provided by Xijing Hospital:

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Treatment Outcome	Aorta Dissection; Aorta Aneurysm; Aorta pseudoaneurysm; Endovascular aortic repair

Additional relevant MeSH terms:

Aneurysm; Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases