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.

Study Overview

• Status: Unknown
• Conditions: Aorta Dissection; Aorta Aneurysm
• Intervention / Treatment: Procedure: Hybrid operation

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

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; Phone Number: 86-13892828016; Email: yangjian1212@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 88 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Thoracic Aortic Dissection

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative MACE	Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoleak	Endoleak of all types from the stent graft	12 months
Stent-graft migration/kinking	Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention	12 months
Cumulative cerebrovascular events	Cumulative cerebrovascular events as bleeding, thrombosis, paraplegia, transient unconsciousness, et al.	12 months
Liver/Kidney dysfunction	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.	12 months

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Changhai Hospital; Shanghai Zhongshan 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

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 28, 2011

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; Hybrid operation; Debranching
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm
• Other Study ID Numbers: XJ-20111126 -2