UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010503 |
|---|---|
| Receipt number | R000012240 |
| Scientific Title | Japan Peripheral Artery disease: endovaScular revaScularizatION prospective multicenter observational study |
| Date of disclosure of the study information | 2013/07/15 |
| Last modified on | 2018/05/02 01:17:20 |
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Basic information
Public title
Japan Peripheral Artery disease: endovaScular revaScularizatION prospective multicenter observational study
Acronym
J-PASSION
Scientific Title
Japan Peripheral Artery disease: endovaScular revaScularizatION prospective multicenter observational study
Scientific Title:Acronym
J-PASSION
Region
| Japan |
Condition
Condition
Peripheral artery disease
Classification by specialty
| Medicine in general | Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical outcomes of endovascular therapy, and the rates of cardio- and cerebrovascular events and survival in Japanese patients with symptomatic peripheral artery disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peripheral artery disease overall:
Comparison of survival and cardiovascuclar event rates at 3 years between intermittent claudication and critical limb ischemia patients. Comparison of repeat intervention rate at 3 years between intermittent claudication and critical limb ischemia patients.
Intermittent claudication group:
Improvement rate of Rutherford class at 1 year, Survival and cardiovascular event rates at 3 years.
Critical limb ischemia group:
Change of visual analogue scale at 1 month, Wound healing rate at 1 year, Limb salvage, survival, amputation-free survival and cardiovascular event rates at 3 years.
Key secondary outcomes
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
20 years old and more.
Informed consent obtained.
Scheduled endovascular therapy for symptomatic peripheral artery disease.
Key exclusion criteria
None.
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osami Kawarada |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan, 565-8565
TEL
06-6833-5012
kawarada90@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujishiro |
Organization
National Cerebral and Cardiovascular Center
Division name
Medical Research
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan, 565-8565
TEL
06-6833-5012
Homepage URL
plandiv@ml.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant, Grants-in-Aid for Scientific Research from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 07 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preinvestigation.
Management information
Registered date
| 2013 | Year | 04 | Month | 16 | Day |
Last modified on
| 2018 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012240
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
