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Total Endovascular Aortic Arch Re-construction Study(TEARS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01496833
First received: December 13, 2011
Last updated: December 30, 2015
Last verified: December 2015
History of Changes
  Purpose
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 Intervention
Aorta Dissection
Aorta Aneurysm
 Device: Ankura Branched/Fenestrated Stent Graft

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Total Endovascular Aortic Arch Re-construction Study(TEARS)------China's Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • cumulative MACE (including death, rupture, paraplegia, aneurysm formation) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Endoleak [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Endoleak of all types

  • Stent-graft migration/kinking [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention

  • cumulative cerebrovascular events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    cumulative cerebrovascular events
Estimated Enrollment: 50
Study Start Date: January 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   12 Years to 90 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496833

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

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01496833     History of Changes
Other Study ID Numbers: XJ-20111126 
Study First Received: December 13, 2011
Last Updated: December 30, 2015
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016