Total Endovascular Aortic Arch Re-construction Study(TEARS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Aorta Dissection; Aorta Aneurysm
• Intervention / Treatment: Device: Ankura Branched/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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 18, 2011
• First Posted (Estimate): December 21, 2011

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases; Treatment Outcome; Aortic Diseases; Aorta Dissection; Aorta Aneurysm; Aorta pseudoaneurysm; Endovascular aortic repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: XJ-20111126