Endovascular Aortic Repair for Aortic Dissection

Sponsor

Xijing Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01505309

Collaborator

Changhai Hospital (Other)

500

Enrollment

Location

Arm

131

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aorta Dissection Aorta Aneurysm	Device: Stent Graft (Medtronic, Microport, Ankura)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endovascular Aortic Repair for Aortic Dissection------XiJing Registry

Study Start Date :

Jan 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stent Graft 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）.	Device: Stent Graft (Medtronic, Microport, Ankura) 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: Medtronic Stent Graft Microport Stent Graft Ankura Stent Graft

Arm

Intervention/Treatment

Experimental: Stent Graft

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）.

Device: Stent Graft (Medtronic, Microport, Ankura)

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:

Medtronic Stent Graft

Microport Stent Graft

Ankura Stent Graft

Outcome Measures

Primary Outcome Measures

Cumulative major adverse cardiac events (MACE) [24 months]
Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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