UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018753 |
|---|---|
| Receipt number | R000021693 |
| Scientific Title | Long term outcome of Endovascular therapy for PAD with intermittent claudication observational prospective multicenter Registry |
| Date of disclosure of the study information | 2015/09/28 |
| Last modified on | 2019/04/01 20:34:08 |
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Basic information
Public title
Long term outcome of Endovascular therapy for PAD with intermittent claudication
observational prospective multicenter Registry
Acronym
ASHIMORI IC REGISTRY
Scientific Title
Long term outcome of Endovascular therapy for PAD with intermittent claudication
observational prospective multicenter Registry
Scientific Title:Acronym
ASHIMORI IC REGISTRY
Region
| Japan |
Condition
Condition
peripheral artery disease with intermittent claudication
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evalutate the outcome 12 months after Endovascular Treatment(EVT) for PAD patients with claudication. Outcomes are efficacy and safty of EVT and, the efficary includes the patency of index lesion and the change of leg symptoms.
We investigate long term outcome 3years after EVT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary patency rate of target vessel 12 months after EVT
Key secondary outcomes
Improvement of leg symptom 12 months after EVT.
Major adverse events (MAE) occurring within 3years after index treatment. MAE is defined as death, myocardial infarction (Q-wave and non-Q-wave), stroke, TVR, or major amputation of index limb
Improvement of leg symptom assessed by 6 minutes walking test
The change in femoral and the below-knee
circumference
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with PAD
2)Patients aged 20 years or older when providing consent
3)Patients providing written consent indicating understanding of and agreement to participate in the study, and willing to undergo follow up at 1, 2, and 3 years after index treatment
4)Patients with an index limb ABI equal to or lower than 0.9, or definite diagnosis of PAD in accordance with ACCF/AHA guidelines if ABI is greater than 0.9.
5)Patients have symptoms including claudication and rest leg pain.
Key exclusion criteria
1)Terminally ill patients expected to live less than one year EVT
2)Patients with ischemic ulcer or gangreen
3)Patients with untreated coagulation or significant bleeding disorders and patients unable to receive anticoagulation or antiplatelet treatment
4)Patients who are or may be pregnant or lactating
5)Patients whose treatment side leg has already been amputated above the ankle
6)to participate in other clinical trials that could possible affect the scientific validity of this study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Okayama University
Division name
Department of Cardiovaclar medicine
Zip code
700-8558
Address
2-5-2 SHIKATACHO KITAKU OKAYAMA CITY
TEL
086-235-7351
hiromail1979@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Toda |
Organization
Okayama University
Division name
Department of Cardiovaclar medicine
Zip code
700-8558
Address
2-5-2 SHIKATACHO KITAKU OKAYAMA CITY
TEL
086-235-7351
Homepage URL
hiromail1979@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Department of Cardiovasclar medicine
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikatatyo Kitaku Okayama City
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
| 2015 | Year | 09 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is prospective cohort study.We investigate patients performed EVT from Jan, 2016 to Mar 2021.
Management information
Registered date
| 2015 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021693
