UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Poor-Risk patients wIth and withOut RevascularIzation TherapY for critical limb ischemia
Title of the study (Brief title)	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	Osamu Iida
Organization	Kansai Rosai Hospital
Division name	Cardiovascular Center
Address	3-1-69 Inabaso, Amagasaki-shi, Hyogo
TEL	06-6416-1221
Email	iida.osa@gmail.com

Public contact
Name of contact person	Osamu Iida
Organization	Kansai Rosai Hospital
Division name	Cardiovascular Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000015029