Endovascular Aortic Repair for Aortic Dissection
|Aorta Dissection Aorta Aneurysm||Device: Stent Graft (Medtronic, Microport, Ankura)|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Endovascular Aortic Repair for Aortic Dissection------XiJing Registry|
- Cumulative major adverse cardiac events (MACE) [ Time Frame: 24 months ]Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)
- Endoleak [ Time Frame: 24 months ]Endoleak of all types from the stent graft
- Stent-graft migration/kinking [ Time Frame: 24 months ]Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Stent Graft
TEVAR procedure using devices include Medtronic Stent Graft（Medtronic Medtronic, Inc., US） Microport Stent Graft（Microport Co.,LTD.，Shanghai, China） Ankura Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）.
Device: Stent Graft (Medtronic, Microport, Ankura)
Medtronic Stent Graft（Medtronic Medtronic, Inc., US） Microport Stent Graft（Microport Co.,LTD.，Shanghai, China） Ankura Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）
Aneurysms and dissection involving the descending 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. The goal of Thoracic Endovascular Aortic Repair (TEVAR) is to re-construct the descending aorta and aortic arch to cover the primary entry tear of the dissection and to remodel the aorta. TEVAR technique were performed with various devices available. The purpose of this study is to investigate the short to mid term efficacy and safety of Thoracic Endovascular Aortic Repair (TEVAR) in patients who had aortic lesions, such as descending aortic/arch aneurysm, pseudo-aneurysm, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505309
|Contact: Jian Yang, MD,PhDfirstname.lastname@example.org|
|Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Jian Yang, M.D.,Ph.D|
|Principal Investigator:||Jian Yang, M.D., Ph.D||Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University|