UMIN-CTR Clinical Trial

Basic information
Public title	Periodical difference of SFA intervention -Multi center retrospective analysis-
Acronym	MK4 study
Scientific Title	Periodical difference of SFA intervention -Multi center retrospective analysis-
Scientific Title:Acronym	MK4 study
Region	Japan

Condition
Condition	Symptomatic Superficial femoral artery (SFA) atherosclerosis occlusive disease
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the real-world endovascular treatment therapy for SFA AIOD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary patency rate
Key secondary outcomes	Free from target lesion revascularization rate, Amputation free rate, all-cause mortality rate

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	From 2010-2018, Successfully EVT for SFA lesions Rutherford category 2-4 de novo lesions
Key exclusion criteria	Rutherford 5-6 In stent restenosis
Target sample size	2800

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Fujihara
Organization	Kishiwada Tokushukai Hospital
Division name	Cardiology
Zip code	595-8522
Address	4-27-1,Kamori-cho,Kishiwada City Osaka,Japan
TEL	072-445-9915
Email	masahiko-fujihara@themis.ocn.ne.jp

Public contact
Name of contact person	1st name Masahiko Middle name Last name Fujihara
Organization	Kishiwada Tokushukai Hospital
Division name	Cardiology
Zip code	595-8522
Address	4-27-1,Kamori-cho,Kishiwada City Osaka,Japan
TEL	072-445-9915
Homepage URL
Email	masahiko-fujihara@themis.ocn.ne.jp

Sponsor
Institute	Kishiwada Tokushukai Hospital
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	Kishiwada Tokushukai Hospital IRB
Address	4-27-1,Kamori-cho,Kishiwada City Osaka,Japan
Tel	072-445-9915
Email	kenji.nakatani@tokushukai.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	岸和田徳洲会病院、小倉記念病院、関西労災病院、森之宮病院、済生会中津病院

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	2800
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	No longer recruiting
Date of protocol fixation	2019 Year 10 Month 31 Day
Date of IRB	2019 Year 10 Month 31 Day
Anticipated trial start date	2019 Year 10 Month 31 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter retrospective observational analysis

Management information
Registered date	2020 Year 04 Month 05 Day
Last modified on	2020 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045682