Hybrid Operation in Thoracic Aortic Dissection

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Xijing Hospital
Sponsor:
Collaborators:
Shanghai Zhongshan Hospital
Changhai Hospital
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01500395
First received: December 22, 2011
Last updated: August 18, 2014
Last verified: August 2014

December 22, 2011
August 18, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
Cumulative MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)
Same as current
Complete list of historical versions of study NCT01500395 on ClinicalTrials.gov Archive Site
  • Endoleak [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Endoleak of all types from the stent graft
  • Stent-graft migration/kinking [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention
  • Cumulative cerebrovascular events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Cumulative cerebrovascular events as bleeding, thrombosis, paraplegia, transient unconsciousness, et al.
  • Liver/Kidney dysfunction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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.

  • Endoleak [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Endoleak of all types from the stent graft
  • Stent-graft migration/kinking [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention
  • Cumulative cerebrovascular events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Cumulative cerebrovascular events as bleeding, thrombosis, paraplegia, transient unconsciousness, et al.
  • Liver/Kidney dysfunction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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.

Not Provided
Not Provided
 
Hybrid Operation in Thoracic Aortic Dissection
Hybrid Operation in Thoracic Aortic Dissection---Registry of China

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Aorta Dissection
  • Aorta Aneurysm
Procedure: Hybrid operation
Hybrid Operations including debranching technique+Thoracic Endovascular Aortic Repair (TEVAR), Frozen elephant trunk technique, aortic arch replacement with concommitant TEVAR, et al. 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).
Other Names:
  • Medtronic Stent Graft
  • Microport Stent Graft
  • Ankura Stent Graft
Experimental: Stent Graft and open surgery
Hybrid Operations including debranching technique+Thoracic Endovascular Aortic Repair (TEVAR), Frozen elephant trunk technique, aortic arch replacement with concommitant TEVAR, et al.
Intervention: Procedure: Hybrid operation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion CriteriaInclusion Criteria:

  • Ascending aortic/arch aneurysm
  • Ascending aortic/arch pseudo-aneurysm
  • Stanford Type A dissection
  • Retrograde Stanford Type B dissection
  • Unclassified dissection with primary tear located in the aortic arch
  • Able to tolerate endotracheal intubation and general anesthesia
  • Subject's anatomy must meet the anatomical criteria to receive that implanted device
  • The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
  • Availability for the appropriate follow-up visits during the follow-up period
  • Capability to follow all study requirements

Exclusion Criteria:

  • ASA classification = V
  • Severe renal insufficiency defined as SVS risk renal status = 3
  • Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
  • Presence of connective tissue disease
  • Active infection or active vasculitides
  • Pregnant woman or positive pregnancy test
  • Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
  • Subject has had a cerebral vascular accident (CVA) within 2 months.
  • History of drug abuse
  • Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
  • Subject has a known allergy or intolerance to the device components.
  • Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
  • Subject has a co-morbidity causing expected survival to be less than 1 year.
  • Enrolment in another clinical study
  • Unwillingness to cooperate with study procedures or follow-up visits
Both
12 Years to 90 Years
No
Contact: Jian Yang, MD,PhD 86-13892828016 yangjian1212@hotmail.com
China
 
NCT01500395
XJ-20111126 -2
Yes
Xijing Hospital
Xijing Hospital
  • Shanghai Zhongshan Hospital
  • Changhai Hospital
Principal Investigator: Dinghua Yi, M.D., Ph.D Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Study Director: Jian Yang, M.D., Ph.D. Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Study Director: Weixun Duan, M.D., Ph.D. Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Study Director: Shiqiang Yu, M.D. Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Study Director: Jincheng Liu, M.D. Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Study Director: Wensheng Chen, M.D. Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Xijing Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP