Clinical trial NCT01505309: Endovascular Aortic Repair for Aortic Dissection
Official title: Endovascular Aortic Repair for Aortic Dissection------XiJing Registry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aorta Dissection
Aorta Aneurysm
Keywords: Aortic Diseases
Vascular Diseases
Cardiovascular Diseases
Treatment Outcome
Aorta Dissection
Aorta Aneurysm
Aorta pseudoaneurysm
Endovascular aortic repair
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
First posted: 2012-01-06
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the short to mid term efficacy and safety of Thoracic Endovascular Aortic Repair (TEVAR) in patients who had aortic lesions, such as descending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.

Detailed description: Aneurysms and dissection involving the descending 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 Thoracic Endovascular Aortic Repair (TEVAR) is to re-construct the descending aorta and aortic arch to cover the primary entry tear of the dissection and to remodel the aorta. TEVAR technique were performed with various devices available. The purpose of this study is to investigate the short to mid term efficacy and safety of Thoracic Endovascular Aortic Repair (TEVAR) in patients who had aortic lesions, such as descending aortic/arch aneurysm, pseudo-aneurysm, 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 Criteria:

* Descending aortic/arch aneurysm
* Descending aortic/arch pseudo-aneurysm
* 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.
* Enrollment in another clinical study
* Unwillingness to cooperate with study procedures or follow-up visits

Primary outcomes:
measure: Cumulative major adverse cardiac events (MACE)
timeFrame: 24 months
Secondary outcomes:
measure: Endoleak
timeFrame: 24 months
measure: Stent-graft migration/kinking
timeFrame: 24 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: Jian Yang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: