Total Endovascular Aortic Arch Re-construction Study(TEARS)

NCT ID: NCT01496833

Last Updated: 2016-01-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-12-31

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.

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.

Conditions

Aorta Dissection; Aorta Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endovascular

Total endovascular arch reconstruction

Group Type: EXPERIMENTAL

Ankura Branched/Fenestrated Stent Graft

Intervention Type: DEVICE

Ankura Branched/Fenestrated Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）

Interventions

Ankura Branched/Fenestrated Stent Graft

Ankura Branched/Fenestrated Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）

Intervention Type: DEVICE

Other Intervention Names

Ankura-TM Stent Graft; Ankura Branched Stent Graft; Ankura Fenestrated Stent Graft

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Yang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

Dinghua Yi, M.D., PhD.

Role: STUDY_CHAIR

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

Locations

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Yang, MD,PhD

Role: CONTACT

yangjian1212@hotmail.com

86-13892828016

Facility Contacts

Jian Yang, MD,PhD

Role: primary

Other Identifiers

XJ-20111126

Identifier Type: -

Identifier Source: org_study_id