Endovascular Aortic Repair for Aortic Dissection

Aorta Aneurysm Clinical Trial

Official title: Endovascular Aortic Repair for Aortic Dissection------XiJing Registry

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aorta Aneurysm
• Aorta Dissection
• Aortic Aneurysm

• NCT number: NCT01505309
• Study type: Interventional
• Source: Xijing Hospital
• Contact: Jian Yang, MD,PhD
• Phone: 86-13892828016
• Email: yangjian1212@hotmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 2008
• Completion date: December 2018