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Endovascular Aortic Repair for Aortic Dissection

This study is currently recruiting participants.
Verified January 2012 by Xijing Hospital
Sponsor:
Collaborator:
Changhai Hospital
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01505309
First received: December 22, 2011
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Aorta Dissection
Aorta Aneurysm
 Device: Stent Graft (Medtronic, Microport, Ankura)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endovascular Aortic Repair for Aortic Dissection------XiJing Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Cumulative major adverse cardiac events (MACE) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)


Secondary Outcome Measures:
  • Endoleak [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Endoleak of all types from the stent graft

  • Stent-graft migration/kinking [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention


Estimated Enrollment: 500
Study Start Date: January 2008
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
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）
Other Names:
  • Medtronic Stent Graft
  • Microport Stent Graft
  • Ankura Stent Graft

Detailed Description:

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.

  Eligibility

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

Inclusion Criteria:

  • Descending aortic/arch aneurysm
  • Descending aortic/arch pseudo-aneurysm
  • 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.
  • Enrollment 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: NCT01505309

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            
Sponsors and Collaborators
Xijing Hospital
Changhai Hospital
Investigators
Principal Investigator: Jian Yang, M.D., Ph.D Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01505309     History of Changes
Other Study ID Numbers: XJ-20111126 -3
Study First Received: December 22, 2011
Last Updated: January 5, 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

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

ClinicalTrials.gov processed this record on May 21, 2013