Hybrid Operation in Thoracic Aortic Dissection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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:
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Outcome Measures
Primary Outcome Measures
- Cumulative MACE [12 months]
Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)
Secondary Outcome Measures
- Endoleak [12 months]
Endoleak of all types from the stent graft
- Stent-graft migration/kinking [12 months]
Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention
- Cumulative cerebrovascular events [12 months]
Cumulative cerebrovascular events as bleeding, thrombosis, paraplegia, transient unconsciousness, et al.
- Liver/Kidney dysfunction [12 months]
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.
Eligibility Criteria
Criteria
Inclusion CriteriaInclusion Criteria:
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Ascending aortic/arch aneurysm
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Ascending aortic/arch pseudo-aneurysm
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Stanford Type A dissection
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Retrograde Stanford Type B dissection
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Unclassified dissection with primary tear located in the aortic arch
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Able to tolerate endotracheal intubation and general anesthesia
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Subject's anatomy must meet the anatomical criteria to receive that implanted device
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The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
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Availability for the appropriate follow-up visits during the follow-up period
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Capability to follow all study requirements
Exclusion Criteria:
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ASA classification = V
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Severe renal insufficiency defined as SVS risk renal status = 3
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Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
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Presence of connective tissue disease
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Active infection or active vasculitides
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Pregnant woman or positive pregnancy test
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Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
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Subject has had a cerebral vascular accident (CVA) within 2 months.
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History of drug abuse
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Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
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Subject has a known allergy or intolerance to the device components.
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Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
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Subject has a co-morbidity causing expected survival to be less than 1 year.
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Enrolment in another clinical study
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Unwillingness to cooperate with study procedures or follow-up visits
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University | Xi'an | Shaanxi | China | 710032 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJ-20111126 -2