Clinical Trial: Hybrid Operation in Thoracic Aortic Dissection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Hybrid Operation in Thoracic Aortic Dissection---Registry of China

Brief Summary: The purpose of this study is to investigate the short to mid term efficacy and safety of different hybrid operations 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. The goal of hybrid operations is to re-construct the ascending aorta and aortic arch to cover the primary entry tear of the dissection and to remodel the aorta. Hybrid Operations including debranching technique+Thoracic Endovascular Aortic Repair (TEVAR), Frozen elephant trunk technique, aortic arch replacement with concommitant TEVAR, et al. The purpose of this study is to investigate the short to mid term efficacy and safety of different hybrid operations 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 [ Time Frame: 12 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Endoleak [ Time Frame: 12 months ]
    Endoleak of all types from the stent graft
  • 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 as bleeding, thrombosis, paraplegia, transient unconsciousness, et al.
  • Liver/Kidney dysfunction [ Time Frame: 12 months ]

    Liver dysfunction including jaundice，transaminase elevation 1.5 times more than normal, et al.

    Kidney dysfunction including oliguria, anuria, Creatinine/BUN elevation 1.5 times more than normal, et al.



Original Secondary Outcome:

  • Endoleak [ Time Frame: 12 months ]
    Endoleak of all types from the stent graft
  • 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 as bleeding, thrombosis, paraplegia, transient unconsciousness, et al.
  • Liver/Kidney dysfunction [ Time Frame: 12 months ]

    Liver dysfunction including jaundice，transaminase elevation 1.5 times more than normal, et al.

    Kidney dysfunction including oliguria, anuria, Cretinine/BUN elevation 1.5 times more than normal, et al.



Information By: Xijing Hospital

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