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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004112
Receipt No. 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

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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
Email 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
Email gen52@nms.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Nippon Medical School
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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