Total Endovascular Aortic Arch Re-construction Study(TEARS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01496833 |
Recruitment Status
:
Recruiting
First Posted
: December 21, 2011
Last Update Posted
: January 1, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aorta Dissection Aorta Aneurysm | Device: Ankura Branched/Fenestrated Stent Graft | Not Applicable |
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 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 |
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:
|
- cumulative MACE (including death, rupture, paraplegia, aneurysm formation) [ Time Frame: 12 months ]
- Endoleak [ Time Frame: 12 months ]Endoleak of all types
- Stent-graft migration/kinking [ Time Frame: 12 months ]Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention
- cumulative cerebrovascular events [ Time Frame: 12 months ]cumulative cerebrovascular events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 90 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496833
Contact: Jian Yang, MD,PhD | 86-13892828016 | yangjian1212@hotmail.com |
China, Shaanxi | |
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University | Recruiting |
Xi'an, Shaanxi, China, 710032 | |
Contact: Jian Yang, MD,PhD |
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 |
Responsible Party: | Xijing Hospital |
ClinicalTrials.gov Identifier: | NCT01496833 History of Changes |
Other Study ID Numbers: |
XJ-20111126 |
First Posted: | December 21, 2011 Key Record Dates |
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 |