aortic arch disease
Conditions
Interventions
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) aortic aneurysm located aortic arch to descending aorta and the following one of features are admitted:. 1-a) the largest diameter exceeds 50mm in fusiform aneurysm 1-b) saccular aneurysm containing the risk of rupture 1-c) rapid expansionary more than 5mm/ year 1-d) symptomatic 1-e) risk of rupture or malperfusion 2) the patient who judges the average artificial blood vessel substitution way dies of more than one cardiovascular surgery medicine or, a possibility of the severe complication development is high, and that it's difficult to enforce safely. 3) treatment in aorta stentgraft approved at present doesn't possess more than 20 mm of normal blood vessel in the left common carotid branch part end, and is difficult. I possess an aorta neck of diameter 18 suitable for stentgraft custody-42 mm in a line aorta on the 4). 5) I possess enough blood vessel access for delivery system [biggest outside diameter 26Fr (8.7 mm)] insertion. 6) after a subject had the explanation about the contents of this research, I'm signing agreement sentences. 7) an examinee and the doctor who does this research agree about that a subject goes to a hospital on all follow up days when it's necessary after hand skill operation.
Exclusion criteria
Exclusion criteria: 1)underage (less than 20). 2)a untreated coronary artery disease 3)severe LV dysfunction(LVEF is less than 20%) 4)the patient with pregnancy. 5)the following one of haematological disorder. (1)Leukocyte decrease (a leukocyte, several 1000 /mm3, less than)(2)Platelet decrease shou (a platelet, several, 50,000 /mm3, less than)(3)Haemorrhagic diathesis or blood clotting abnormality. 6)the morbid overweight patient who can't take a picture of an X-ray picture of an aorta appropriately. 7)chronic obstructive pulmonary disease which requires O Ther outside the hospital daily (COPD) is admitted. 8)it's following hyperesthesia to whether it's both or taboo, and it can't be treated appropriately beforehand.(1)Contrast medium(2)NICHINORU (titanium and nickel alloy), platinum iridium base alloy and polyester(3)Heparin 9)an active whole body infection and/or, patient with infectibility big aneurysm. 10) the past of the cerebrovascular accident (CVA) or a transient brain ischemia attack (TIA) is within 1 month old from a schedule operation day. 11)active enteron bleeding. 12)the patient diagnosed as life expectancy for less than 1 year based on a clear basis (existence of malignant tumor and aging) medically. 13)the patient who participates in a clinical trial of other medical equipment or medical supplies. 14)it seems to refuse blood transfusion. 15)serious recognition shou (As a result, it isn't possible to do the life which became independent outside the Long Term Care Facility to which an agreement explanation note can't be submitted or a hand skill and going to a hospital for follow-up won't be done for a rehabilitation.) 16)the patient who judged a doctor in attendance when it was medical to participate in clinical study psychologically and was difficult. (anatomilcal contraindication) beyond information for use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| freedom from aortic rupture/enlargement at 6 month postoperatively | — |
Countries
Japan
Contacts
Public ContactAkihiro Yoshitake
Keio University School of Medicine Department of Cardiovascular Surgery
Outcome results
None listed