UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002368 |
|---|---|
| Receipt number | 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 11:08:11 |
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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
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
sogacchy@yahoo.co.jp
Sponsor or person
Institute
Kokura Memorial hospital department of cardiology
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002906
