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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012871
Receipt No. 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

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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
Last 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
Email iida.osa@gmail.com

Public contact
1st 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
Email iida.osa@gmail.com

Sponsor
Institute PRIORITY Registry Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015029

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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