Hybrid Operation in Thoracic Aortic Dissection

NCT01500395 | Unknown DMC

• 1 other identifier: XJ-20111126 -2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aorta Dissection; Aorta Aneurysm

Keywords

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Treatment Outcome; Aorta Dissection; Aorta Aneurysm; Aorta pseudoaneurysm; Endovascular aortic repair; Hybrid operation; Debranching

Outcome Measures

Primary Outcomes (1)

• Cumulative MACE

  Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)

  12 months

Secondary Outcomes (4)

• Endoleak

  12 months

• Stent-graft migration/kinking

  12 months

• Cumulative cerebrovascular events

  12 months

• Liver/Kidney dysfunction

  12 months

Study Arms (1)

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

Interventions

Hybrid operation PROCEDURE

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）.

Also known as: Medtronic Stent Graft, Microport Stent Graft, Ankura Stent Graft

Stent Graft and open surgery

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Thoracic Aortic Dissection

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Changhai Hospital: collaborator

Study Sites (1)

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Aortic Aneurysm; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Acute Aortic Syndrome

Study Officials

• Dinghua Yi, M.D., Ph.D

  Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Jian Yang, MD,PhD

CONTACT

86-13892828016; yangjian1212@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2018
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

CN (1)