UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011717 |
|---|---|
| Receipt number | R000013697 |
| Scientific Title | Determination of effective remodeling duration after thoracic endovascular repair for type B aortic dissection |
| Date of disclosure of the study information | 2013/09/11 |
| Last modified on | 2020/10/23 12:04:33 |
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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 ≥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.
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
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
tsakamoto8112@gmail.com
Sponsor or person
Institute
Osaka University Graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013697
