Hybrid Operation in Thoracic Aortic Dissection

Aorta Aneurysm Clinical Trial

Official title:

Hybrid Operation in Thoracic Aortic Dissection---Registry of China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01500395
• Other study ID #: XJ-20111126 -2
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2011
• Last updated: December 30, 2015
• Start date: November 2011
• Est. completion date: December 2018

Study information

• Verified date: December 2015
• Source: Xijing Hospital
• Contact: Jian Yang, MD,PhD
• Phone: 86-13892828016
• Email: yangjian1212[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aorta Aneurysm
• Aorta Dissection
• Aortic Aneurysm

Intervention

Procedure:
• Hybrid operation
Hybrid Operations including debranching technique+Thoracic Endovascular Aortic Repair (TEVAR), Frozen elephant trunk technique, aortic arch replacement with concommitant TEVAR, et al. 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).

Locations

Country	Name	City	State
China	Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (3)

Lead Sponsor	Collaborator
Xijing Hospital	Changhai Hospital, Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative MACE	Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)	12 months	Yes
Secondary	Endoleak	Endoleak of all types from the stent graft	12 months	Yes
Secondary	Stent-graft migration/kinking	Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention	12 months	Yes
Secondary	Cumulative cerebrovascular events	Cumulative cerebrovascular events as bleeding, thrombosis, paraplegia, transient unconsciousness, et al.	12 months	Yes
Secondary	Liver/Kidney dysfunction	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.	12 months	Yes