UMIN-CTR Clinical Trial

Basic information
Public title	Long-term outcomes of endovascular treatment for peripheral artery disease in Kumamoto multicenter registry
Acronym	Kumamoto EVT registry
Scientific Title	Long-term outcomes of endovascular treatment for peripheral artery disease in Kumamoto multicenter registry
Scientific Title:Acronym	Kumamoto EVT registry
Region	Japan

Condition
Condition	peripheral artery disease
Classification by specialty	Cardiology Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We accumulate present data of endovascular treatment for peripheral arterial disease and compare the results between conventional therapeutic devices and novel ones. We also assess the difficulty of treatment by lesion properties and the risk of restenosis in multicenter. We assess and clarify the future therapeutic problems.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Target Vessel Revascularization:TVR 2. Improvement of maximun walk distance
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Symptomatic lower peripheral artery disease patients more than 20 years old who undergo endovascular treatment (EVT).
Key exclusion criteria	1) No consent for this study. 2) Scheduled bypass grafting or lower leg amputation. 3) Patients less than 20 years old. 4) Life expectancy less than 1 year. 5) Acute limb ischemia. 6) Patients who have the difficulty for use of contrast media due to allergy or severe renal dysfunction. 7) Patients who have the difficulty for anti-thrombotic therapy. 8) Patients who take part in the other study. 9) In case the chief researcher decides the enrolled patients is inappropriate for this study. 10) EVT for deep femoral artery only 11) Rutherford 6
Target sample size	1500

Research contact person
Last name of lead principal investigator	1st name Kenichi Middle name Last name Tsujita
Organization	Kumamoto University
Division name	Department of Cardiovascular Medicine Graduate School of Medical Sciences
Zip code	8608556
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
TEL	81-96-373-5175
Email	tsujita@kumamoto-u.ac.jp

Public contact
1st name of contact person	1st name Koichiro Middle name Last name Fujisue
Organization	Kumamoto University
Division name	Department of Cardiovascular Medicine Graduate School of Medical Sciences
Zip code	8608556
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
TEL	81-96-373-5175
Homepage URL
Email	fujisues@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

Funding Source
Organization	none
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	the Human Ethics Review Committee of Kumamoto University Graduate School of Medicine
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
Tel	81-96-373-5657
Email	byi-senshin@jimu.kumamoto-u.ac.jp

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	2018 Year 10 Month 30 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	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 18 Day
Date of IRB	2017 Year 10 Month 18 Day
Anticipated trial start date	2017 Year 10 Month 18 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2018 Year 10 Month 30 Day
Last modified on	2019 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039560