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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007213
Receipt No. R000008490
Scientific Title Next-gen Fenestrated Endgraft to seek indication Expansion for arch aneurysm treatment
Date of disclosure of the study information 2012/02/02
Last modified on 2012/02/02

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Basic information
Public title Next-gen Fenestrated Endgraft to seek indication Expansion for arch aneurysm treatment
Acronym TEVAR using Next-gen Fenestrated Endgraft
Scientific Title Next-gen Fenestrated Endgraft to seek indication Expansion for arch aneurysm treatment
Scientific Title:Acronym TEVAR using Next-gen Fenestrated Endgraft
Region
Japan

Condition
Condition Thoracic aortic aneurysm with unsuitable anatomy for endovascular repair using current stent-grafts
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This large multicenter trial assess the efficacy and safety of thoracic stent-graft system developed by Dr.Yokoi and colleagues.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Aneurysm related event-free survival rate at one year
Key secondary outcomes Evaluation of the efficacy and safety such as primary success rate and rate of major complication

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 All patients are undergone TEVAR(Thoracic Endovascular Aneurysm Repair) for thoracic aortic aneurysm.Tokyo Women's Medical University provide homemade stent graft to every institutes.
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 Patients are identified as those with at least one of the following:
1,An thoracic aortic aneurysm more than 50 mm wide.
2,The aneurysm has enlarged by more than 5 mm in less than 12 months.
3,Saccular aneurysm larger than normal 10mm in maximum transverse diameter
Key exclusion criteria 1,Less than 20 years old
2,Pregnant females
3,Estimated life expectancy of less than twelve months.
4,Never indicate thier intention
5,With NYHA class IV
6,Recent (within three (3) months) myocardial infarction.
7,Recent (within three months) Cerebral Vascular
Accident (CVA).
8,Connective tissue disease (e.g., Marfans and Ehlers-Danlos syndrome).
9,History of bleeding diathesis(including high DIC score, more than 6, caused by aneurysm without palliative therapy) coagulopathy, or refuses blood transfusions.
10,Sensitivities or allergies to stainless steel, ePTFE, PVDF, contrast media, heparin.
11,With unclear cerebellar arteries circle of Willis ,who need to be blocked their subclavian artery with stent graft without bilateral suclavian artery bypass beforehand.
12,Never plan to be blocked their left subclavian artery with less than 10mm proximal landing zone from left subclavialn artery to aneurysm .
13,Never plan to be blocked their left carotid artery with less than 10mm proximal landing zone from left carotid artery to aneurysm.
14,Never plan to be blocked their brachiocephalic trunk with less than 10mm proximal landing zone from brachiocephalic trunk to aneurysm.
15,Plan to be blocked their celiac trunk with unclear connection from SMA to celiac trunk via pancreaticoduodenal arcade.
16,Plan to be blocked their celiac trunk with less than 15mm proximal landing zone from SMA to aneurysm.
17,Never plan to be blocked their celiac trunk with less than 15mm proximal landing zone from celiac trunk to aneurysm.
18,Unfavorable access route with calcification, stenosis and tortuous iliac.
19,Unfavorable landing zone with calcification, mural hematoma and athero.
20,Significant formation of atheroma in access route and are concerned with risk of atherothrombosis.
21,Thoracic aneurysm with a contained rupture.
22,With less than 18mm and more than 43mm aortic diameter in proximal landing zone.
23,With active systemic infections
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Yamazaki
Organization Tokyo Women's Medical University
Division name Cardiovascular surgery
Zip code
Address 8-1 Kawadacho Shinjyuku,Tokyo
TEL 03-3353-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Azuma
Organization Tokyo Women's Medical University
Division name Cardiovascularsurgery
Zip code
Address 8-1 Kawadacho Shinjyuku, Tokyo
TEL 03-3353-8111
Homepage URL
Email azumaro-ham@umin.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
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 札幌医科大学、岩手医科大学附属病院、仙台厚生病院、東北大学病院、東北厚生年金病院、仙台循環器病センター、埼玉県立循環器・呼吸器病センター、獨協医科大学越谷病院、自治医科大学附属さいたま医療センター、戸田中央総合病院、埼玉東部循環器病院、千葉県循環器病センター、船橋市立医療センター、慶應義塾大学病院、東京女子医科大学、綾瀬循環器病院、横浜市立大学附属市民総合医療センター、聖隷浜松病院、新潟大学医歯学総合病院、金沢医科大学病院、富山県立中央病院、自治医科大学附属病院、山梨県立中央病院、三重大学医学部附属病院、奈良県立医科大学附属病院、大阪大学医学部附属病院、森ノ宮病院、松原徳洲会病院、八尾徳洲会病院、京都府立医科大学附属病院、兵庫医科大学病院 、岡山大学病院、岡山医療センター、済生会今治病院、香川県立中央病院、近森病院、愛媛県立中央病院、島根県立中央病院、松江赤十字病院、山口県立総合医療センター、久留米大学病院、九州大学病院、小倉記念病院、麻生飯塚病院、佐賀大学医学部附属病院、熊本中央病院、熊本大学医学部附属病院、熊本医療センター、熊本済生会病院、大村市民病院、鹿児島大学病院、大隅鹿屋病院、琉球大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 02 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 Open public recruiting
Date of protocol fixation
2011 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2016 Year 10 Month 01 Day
Date of closure to data entry
2017 Year 04 Month 01 Day
Date trial data considered complete
2017 Year 04 Month 01 Day
Date analysis concluded
2017 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 02 Day
Last modified on
2012 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008490

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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