Determination of effective remodeling duration after thoracic endovascular repair for type B aortic dissectio

Not Applicable

• Conditions: Stanford type B dissecting aortic aneurysm

• Registration Number: JPRN-UMIN000011717
• Lead Sponsor: Osaka University Graduate school of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-11
• Study Completion: 2016-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1.Less than 20 years of age 2.Patients with unknown date of onset of dissection 3.Absence of false lumen 5mm or greater in the descending aorta(distal to potential implantation site) 4.A lesion of the basilar aorta, ascending aorta, aortic arch, or abdominal aorta, which requires treatment 5.Treatment history of aneurysms of the aortic arch, descending aorta, or abdominal aorta 6.Patients with infective aortitis or systemic infection for whom endoprosthesis infection is suspected. 7.Continuously in shock state 8.Complication of severe organ disorder a.Low cardiac function b.Advanced Mitral/Aortic regurgitation c.Low respiratory function d.Hepatic cirrhosis e.Irreversible renal failure 9.Patients who have undergone coronary angioplasty within 2 weeks of the procedure 10.Patients with untreated and clinically significant coronary artery disease which requires revascularization 11.Patients with active peptic ulcer 12.Patients who have had cerebral infarction within 4 weeks after the procedure 13.Patients with a life expectancy of less than 12 months due to a non-aortic-related pre-operative complication 14.Pregnant women 15.Major surgery within 30 days of the procedure 16Connective tissue disorder 17.Participation in another clinical study in the past year 18.History of drug abuse, such as narcotics 19.Tortuous aorta or iliac artery for which the endoprosthesis access is considered impossible 20.A case that requires celiac artery closure as a part of treatment 21.Patients to be treated with devices other than CTAG 22.With history of allergy to endoprosthesis materials or contrast agent 23.Other patients for which treatment with endoprosthesis intervention under general anesthesia is considered inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy primary endpoint Aortic remodeling rate at 6 months post-procedure Safety primary endpoint Mortality and MAE incidence rate at 30 days post-procedure