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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002368
Receipt No. R000002906
Scientific Title Clinical Follow-Up After Endovascular Treatment in Patients with Intermittent Claudication
Date of disclosure of the study information 2009/08/24
Last modified on 2009/08/23

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Basic information
Public title Clinical Follow-Up After Endovascular Treatment in Patients with Intermittent Claudication
Acronym Clinical Follow-Up After Endovascular Treatment in Patients with Intermittent Claudication
Scientific Title Clinical Follow-Up After Endovascular Treatment in Patients with Intermittent Claudication
Scientific Title:Acronym Clinical Follow-Up After Endovascular Treatment in Patients with Intermittent Claudication
Region
Japan

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

Objectives
Narrative objectives1 long-term follow-up study in claudicant patients after endvascular therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Freedom from all-cause death
Key secondary outcomes major adverse cardiovascular event(death, myocardial infarctin and stroke), target lesion revascularization, target vessel revascularization, critical limb ischemia, amputation

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

Not applicable
Gender Male and Female
Key inclusion criteria patients with intermittent claudication underwent elective endvascular therapy for de novo lesion in native arteries of lower extremities
Key exclusion criteria critical limb ischemia, acute onset limb ischemia and previous EVT or bypass surgery, urgent procedure
Target sample size 271

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimitsu Soga
Organization Kokura Memorial hospital
Division name cardiology
Zip code
Address 1-1 Kifune-machi Kokurakita-ku Kitakyushu
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimitsu Soga
Organization Kokura Memorial hospital
Division name cardiology
Zip code
Address
TEL
Homepage URL
Email sogacchy@yahoo.co.jp

Sponsor
Institute Kokura Memorial hospital department of cardiology
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
2009 Year 08 Month 24 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 Completed
Date of protocol fixation
2009 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2009 Year 08 Month 01 Day
Date of closure to data entry
2009 Year 08 Month 01 Day
Date trial data considered complete
2009 Year 08 Month 01 Day
Date analysis concluded
2009 Year 08 Month 01 Day

Other
Other related information Baseline clinical characteristics and procedural data were collected from hospital charts or databases.
Clinical follow-up data were obtained by either a review of the hospital records or telephone contacts with the patients or their referring physicians.

Management information
Registered date
2009 Year 08 Month 23 Day
Last modified on
2009 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002906

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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