UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan Peripheral Artery disease: endovaScular revaScularizatION prospective multicenter observational study
Title of the study (Brief title)	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	Osami Kawarada
Organization	National Cerebral and Cardiovascular Center
Division name	Cardiovascular Medicine
Address	5-7-1 Fujishirodai, Suita, Osaka, Japan, 565-8565
TEL	06-6833-5012
Email	kawarada90@hotmail.com

Public contact
Name of contact person	Fujishiro
Organization	National Cerebral and Cardiovascular Center
Division name	Medical Research
Address	5-7-1 Fujishirodai, Suita, Osaka, Japan, 565-8565
TEL	06-6833-5012
Homepage URL
Email	plandiv@ml.ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2013 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012240