Clinical Trial: Total Endovascular Aortic Arch Re-construction Study(TEARS)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Total Endovascular Aortic Arch Re-construction Study(TEARS)------China's Registry
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 Summary:
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.
Sponsor: Xijing Hospital
Current Primary Outcome: cumulative MACE (including death, rupture, paraplegia, aneurysm formation) [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Xijing Hospital
Dates:
Date Received: December 13, 2011
Date Started: January 2015
Date Completion: December 2018
Last Updated: December 30, 2015
Last Verified: December 2015
