Endovascular Aortic Repair for Aortic Dissection
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|ClinicalTrials.gov Identifier: NCT01505309|
Recruitment Status : Recruiting
First Posted : January 6, 2012
Last Update Posted : January 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Aorta Dissection Aorta Aneurysm||Device: Stent Graft (Medtronic, Microport, Ankura)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endovascular Aortic Repair for Aortic Dissection------XiJing Registry|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2018|
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）
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|