UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013989 |
|---|---|
| Receipt number | 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 19:54:13 |
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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
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
k-y.suzuki@nifty.com
Sponsor or person
Institute
REAL-AI
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016282
