Clinical Trial: Endovascular Aortic Repair for Aortic Dissection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Endovascular Aortic Repair for Aortic Dissection------XiJing Registry

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Xijing Hospital

Current Primary Outcome: Cumulative major adverse cardiac events (MACE) [ Time Frame: 24 months ]

Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Xijing Hospital

Dates:
Date Received: December 22, 2011
Date Started: January 2008
Date Completion: December 2018
Last Updated: December 30, 2015
Last Verified: December 2015