UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012871 |
|---|---|
| Receipt number | R000015029 |
| Scientific Title | Poor-Risk patients wIth and withOut RevascularIzation TherapY for critical limb ischemia |
| Date of disclosure of the study information | 2014/01/20 |
| Last modified on | 2018/07/23 14:28:01 |
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Basic information
Public title
Poor-Risk patients wIth and withOut RevascularIzation TherapY for critical limb ischemia
Acronym
PRIORITY Registry
Scientific Title
Poor-Risk patients wIth and withOut RevascularIzation TherapY for critical limb ischemia
Scientific Title:Acronym
PRIORITY Registry
Region
| Japan |
Condition
Condition
Critical Limb Ischemia
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of endovascular and surgical revascularization for CLI patients with impaired activities of daily living or dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
12-months survival rate after registration
Key secondary outcomes
a. cause-specific death rate
b. major amputation rate
c. amputation-free survival rate
d. presence or absence of rest pain after revascularization, ADL, QOL, total number of revascularization
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
a. Patients and their families who can provide an informed consent and patients are aged 20 years or older when providing the consent.
b. CLI has been diagnosed in one or both limbs.
c. Patients who need assistance in daily living because of impaired ADL or dementia.
Key exclusion criteria
patient may not complete follow up at 12 follow up
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular Center
Zip code
Address
3-1-69 Inabaso, Amagasaki-shi, Hyogo
TEL
06-6416-1221
iida.osa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular Center
Zip code
Address
3-1-69 Inabaso, Amagasaki-shi, Hyogo
TEL
06-6416-1221
Homepage URL
iida.osa@gmail.com
Sponsor or person
Institute
PRIORITY Registry Study Group
Institute
Department
Personal name
Funding Source
Organization
PRIORITY Registry Study Group
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Iida O, et al. Prognostic Impact of Revascularization in Poor-Risk Patients With Critical Limb Ischemia: The PRIORITY Registry (Poor-Risk Patients With and Without Revascularization Therapy for Critical Limb Ischemia). JACC Cardiovasc Interv. 10: 1147-1157, 2017.
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
| 2014 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2014 | Year | 01 | Month | 16 | Day |
Last modified on
| 2018 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015029
