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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013989
Receipt No. R000016282
Scientific Title The Impact of Endovascular Therapy for Aorto-iliac TASC D Lesions
Date of disclosure of the study information 2014/05/19
Last modified on 2014/05/18

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Basic information
Public title The Impact of Endovascular Therapy for Aorto-iliac TASC D Lesions
Acronym The Impact of Endovascular Therapy for Aorto-iliac TASC D Lesions
Scientific Title The Impact of Endovascular Therapy for Aorto-iliac TASC D Lesions
Scientific Title:Acronym The Impact of Endovascular Therapy for Aorto-iliac TASC D Lesions
Region
Japan

Condition
Condition Peripheral arterial disease
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to validate the efficacy and safety of EVT for TASC D lesions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In TASC D patients, independent predictors for MACLE.
Key secondary outcomes Success rate, complicatoin rate, primary patency, and MACLE of TASC D and A-C,

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria From Jan. 2005 to Dec. 2009, consecutive patients undergoing stent deployment for de novo aortoiliac lesions were enrolled.
Key exclusion criteria asymptomatic or unknown symptom before EVT, treatment with angioplasty alone, restenotic lesions, history of lower extremities bypass surgery or EVT, acute onset limb ischemia
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Suzuki
Organization Sendai Kousei Hospital
Division name Cardiovascular center
Zip code
Address 4-15, Hirosemachi, Aobaku, Sendai
TEL 022-222-6181
Email k-y.suzuki@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Suzuki
Organization REAL-AI
Division name TASC D subanalysis
Zip code
Address 4-15, Hirosemachi, Aobaku, Sendai
TEL 022-222-6181
Homepage URL
Email k-y.suzuki@nifty.com

Sponsor
Institute REAL-AI
Institute
Department

Funding Source
Organization None
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
2014 Year 05 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This data was retrospective analysis, we studied EVT data from Jan, 2005 to Dec 2009.

Management information
Registered date
2014 Year 05 Month 18 Day
Last modified on
2014 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016282

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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