Stanford type B dissecting aortic aneurysm
Conditions
Interventions
Treat Stanford type-B dissection with stent graft and follow up with patients for 12 months post-operatively.
Sponsors
Osaka University Graduate school of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1The false lumen of aortic dissection meets all of the following conditions. To reside beyond the origin of the left subclavian artery Blood flows inside the false lumen (double-barrel type or partial thrombosis). Existence of the false lumen in size of ≥5 mm in the descending aorta (distal to the site where the endoprosthesis is going to be inserted.) 2.The condition of aortic dissection meets any of the following: a.Rupture b.Malperfusion syndrome c.Maximum diameter of the dissecting aorta not less than 40 mm d.Rapid dilatation of the dissection lumen (≥5 mm/year) e.Partial thrombosis f.Persistent pain g.Hypertension that is difficult to control 3.The stent-graft implantation site meets all of the following conditions. a.The most proximal extent of the implantation site is a non-dissected area. b.Aortic diameter of 16–42 mm, sealing distance from the primary entry tear of ≥20 mm c.No severe calcification or high volume of mural thrombi. 4.The proximal end of stent graft is distal to the brachiocepharic artery / Zone 1 . 5.After the nature of the study is fully explained, the subject or subject's legally acceptable representative has consented and signed an informed consent form, which had been approved by the Institutional Review Board of each study center. 6.The subject and treating surgeon have agreed that the subject is to return to the hospital on all necessary follow-up visits after implantation.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy primary endpoint Aortic remodeling rate at 6 months post-procedure Safety primary endpoint Mortality and MAE incidence rate at 30 days post-procedure | — |
Countries
Japan
Contacts
Public ContactTomohiko Sakamoto
Osaka University Hospital Department of Cardiovascular Surgery
Outcome results
None listed