UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004112 |
|---|---|
| Receipt number | R000004917 |
| Scientific Title | Clinical Follow-Up After Vascular Therapy in Patients with Critical Limb Ischemia |
| Date of disclosure of the study information | 2010/08/28 |
| Last modified on | 2019/03/16 15:56:04 |
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Basic information
Public title
Clinical Follow-Up After Vascular Therapy in Patients with Critical Limb Ischemia
Acronym
Clinical Follow-Up After Vascular Therapy in Patients with Critical Limb Ischemia
Scientific Title
Clinical Follow-Up After Vascular Therapy in Patients with Critical Limb Ischemia
Scientific Title:Acronym
Clinical Follow-Up After Vascular Therapy in Patients with Critical Limb Ischemia
Region
| Japan |
Condition
Condition
Peripheral Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Long-term follow-up study in CLI patients after vascular treatment
Basic objectives2
Safety,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 infarction and stroke), target vessel revascularization, limb 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
Medical refractory patients against conventional therapy, whom were performed any kinds of vascular therapy (bypass graft surgery, catheter intervention, and vascular regenerative therapy).
Key exclusion criteria
1) no evidence of angiological stenosis confirmed by angiography, 2) history of vascular surgery (within 30 days), 3) presence of any malignant disease or history of its treatment within 5 years, 4) untreated proliferative diabetic retinopathy, 5) smoker unable to quit smoking, 6) drug addiction of any kind (including alcohol), 7) evidence of active viral infection, 8) infectious osteomyelitis, and 9) complication of any serious disease affecting the patient's general condition
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Gen |
| Middle name | |
| Last name | Takagi |
Organization
Nippon Medical School
Division name
Department of Cardiovascular Medicine
Zip code
113 8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
gen52@nms.ac.jp
Public contact
Name of contact person
| 1st name | Gen |
| Middle name | |
| Last name | Takagi |
Organization
Nippon Medical School
Division name
Department of Cardiovascular Medicine
Zip code
113 8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
gen52@nms.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
JSPS-Kakenhi
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB-Nippon Medical School
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
clinicaltrial@nms.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
日本医科大学付属病院(Nippon Medical School, University Hospital)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | 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
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Baseline clinical characteristics and procedural data were collected from hospital charts or databases. Clinical follow-up data were obtained from either a review of the hospital records or telephone contacts with the patients or their referring physicians.
Management information
Registered date
| 2010 | Year | 08 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004917
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
