Endovascular Aortic Repair for Aortic Dissection

Endovascular Aortic Repair for Aortic Dissection------XiJing Registry

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.

Study Overview

• Status: Unknown
• Conditions: Aorta Dissection; Aorta Aneurysm
• Intervention / Treatment: Device: Stent Graft (Medtronic, Microport, Ankura)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Yang, MD,PhD; Phone Number: 86-13892828016; Email: yangjian1212@hotmail.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
      • Contact: Jian Yang, M.D.,Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative major adverse cardiac events (MACE)	Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoleak	Endoleak of all types from the stent graft	24 months
Stent-graft migration/kinking	Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention	24 months

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Changhai Hospital
• Investigators: Principal Investigator: Jian Yang, M.D., Ph.D, Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 6, 2012

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases; Treatment Outcome; Aortic Diseases; Aorta Dissection; Aorta Aneurysm; Aorta pseudoaneurysm; Endovascular aortic repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm
• Other Study ID Numbers: XJ-20111126 -3