Clinical trial NCT01500395: Hybrid Operation in Thoracic Aortic Dissection
Official title: Hybrid Operation in Thoracic Aortic Dissection---Registry of China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Changhai Hospital
First posted: 2011-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Thoracic Aortic Dissection

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative MACE
timeFrame: 12 months
Secondary outcomes:
measure: Endoleak
timeFrame: 12 months
measure: Stent-graft migration/kinking
timeFrame: 12 months
measure: Cumulative cerebrovascular events
timeFrame: 12 months
measure: Liver/Kidney dysfunction
timeFrame: 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
name: Dinghua Yi, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
name: Jian Yang, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
name: Weixun Duan, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
name: Shiqiang Yu, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
name: Jincheng Liu, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
name: Wensheng Chen, M.D.
role: STUDY_DIRECTOR
References: