Endovascular Aortic Repair for Aortic Dissection

Not Applicable

• Conditions: Aorta Aneurysm; Aorta Dissection
• Interventions: Device: Stent Graft (Medtronic, Microport, Ankura)

• Registration Number: NCT01505309
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2016-01-01
• Primary Completion: 2016-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stent Graft	Stent Graft (Medtronic, Microport, Ankura)	TEVAR procedure using 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）.

Primary Outcome Measures

Name	Time	Method
Cumulative major adverse cardiac events (MACE)	24 months	Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)

Secondary Outcome Measures

Name	Time	Method
Stent-graft migration/kinking	24 months	Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention
Endoleak	24 months	Endoleak of all types from the stent graft

Trial Locations

Locations (1)

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