UMIN-CTR Clinical Trial

Basic information
Public title	Determination of effective remodeling duration after thoracic endovascular repair for type B aortic dissection
Acronym	Determination of effective remodeling duration after thoracic endovascular repair for type B aortic dissection
Scientific Title	Determination of effective remodeling duration after thoracic endovascular repair for type B aortic dissection
Scientific Title:Acronym	Determination of effective remodeling duration after thoracic endovascular repair for type B aortic dissection
Region	Japan

Condition
Condition	Stanford type B dissecting aortic aneurysm
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of the entry closure using a stent graft indicated for aortic dissection (CTAG) in patients with Stanford type B dissecting aortic aneurysm and to determine the duration from the onset of aortic dissection that allows effective aortic remodeling to occur (effective remodeling duration or ERD).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy primary endpoint Aortic remodeling rate at 6 months post-procedure Safety primary endpoint Mortality and MAE incidence rate at 30 days post-procedure
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	Device,equipment
Interventions/Control_1	Treat Stanford type-B dissection with stent graft and follow up with patients for 12 months post-operatively.
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	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 &#8805;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 (&#8805;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&#8211;42 mm, sealing distance from the primary entry tear of &#8805;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.
Key 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
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshiki Sawa
Organization	Osaka University Hospital
Division name	Department of Cardiovascular Surgery
Zip code
Address	2-15 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3154
Email	tsakamoto8112@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Tomohiko Sakamoto
Organization	Osaka University Hospital
Division name	Department of Cardiovascular Surgery
Zip code
Address	2-15 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3154
Homepage URL
Email	tsakamoto8112@gmail.com

Sponsor
Institute	Osaka University Graduate school of medicine
Institute
Department

Funding Source
Organization	Osaka University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2013 Year 09 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 02 Month 13 Day
Date of IRB	2012 Year 11 Month 06 Day
Anticipated trial start date	2012 Year 11 Month 18 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 09 Month 11 Day
Last modified on	2020 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013697