Hybrid Operation in Thoracic Aortic Dissection

This study is currently recruiting participants.
Verified January 2012 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: January 12, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Aorta Dissection
Aorta Aneurysm
Procedure: Hybrid operation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Hybrid Operation in Thoracic Aortic Dissection---Registry of China

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Cumulative MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500395

Contacts
Contact: Jian Yang, MD,PhD 86-13892828016 yangjian1212@hotmail.com

Locations
China, Shaanxi
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Jian Yang, M.D., Ph.D    86-13892828016    yangjian1212@hotmail.com   
Sponsors and Collaborators
Xijing Hospital
Shanghai Zhongshan Hospital
Changhai Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01500395     History of Changes
Other Study ID Numbers: XJ-20111126 -2
Study First Received: December 22, 2011
Last Updated: January 12, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases
Treatment Outcome
Aorta Dissection
Aorta Aneurysm
Aorta pseudoaneurysm
Endovascular aortic repair
Hybrid operation
Debranching

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 17, 2014