Hybrid Operation in Thoracic Aortic Dissection

• Conditions: Aorta Dissection; Aorta Aneurysm
• Interventions: Procedure: Hybrid operation

• Registration Number: NCT01500395
• Lead Sponsor: Xijing Hospital

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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-28
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2016-01-01
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stent Graft and open surgery	Hybrid operation	Hybrid Operations including debranching technique+Thoracic Endovascular Aortic Repair (TEVAR), Frozen elephant trunk technique, aortic arch replacement with concommitant TEVAR, et al.

Primary Outcome Measures

Name	Time	Method
Cumulative MACE	12 months	Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China