Total Endovascular Aortic Arch Re-construction Study(TEARS)

Aorta Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01496833
• Other study ID #: XJ-20111126
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2011
• Last updated: December 30, 2015
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2015
• Source: Xijing Hospital
• Contact: Jian Yang, MD,PhD
• Phone: 86-13892828016
• Email: yangjian1212[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aorta Aneurysm
• Aorta Dissection
• Aortic Aneurysm

Intervention

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

Locations

Country	Name	City	State
China	Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative MACE (including death, rupture, paraplegia, aneurysm formation)		12 months	Yes
Secondary	Endoleak	Endoleak of all types	12 months	Yes
Secondary	Stent-graft migration/kinking	Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention	12 months	Yes
Secondary	cumulative cerebrovascular events	cumulative cerebrovascular events	12 months	Yes