UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007213 |
|---|---|
| Receipt number | 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 16:10:48 |
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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
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
azumaro-ham@umin.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008490
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| Registered date | File name |
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| Registered date | File name |
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