UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for effectiveness and safety of branched stent-graft to aortic arch disease
Title of the study (Brief title)	Research for effectiveness and safety of branched stent-graft to aortic arch disease
Region	Japan

Condition
Condition	aortic arch disease
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the effectiveness and safety of branched stent graft to aortic arch disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	freedom from aortic rupture/enlargement at 6 month postoperatively
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Endovascular arotic repair
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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
Target sample size	20

Research contact person
Name of lead principal investigator	Hideyuki Shimizu
Organization	Keio University School of Medicine
Division name	Department of Cardiovascular Surgery
Address	35 Shinanomachi, Shinjuku, Tokyo 160-8582, JAPAN
TEL	03-3353-1211
Email	hideyuki@keio.jp

Public contact
Name of contact person	Akihiro Yoshitake
Organization	Keio University School of Medicine
Division name	Department of Cardiovascular Surgery
Address	35 Shinanomachi, Shinjuku, Tokyo 160-8582, JAPAN
TEL	03-3353-1211
Homepage URL
Email	akihiro197253@yahoo.co.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 08 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 11 Day
Last modified on	2017 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024698