UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of clinical outcome after endovascular therapy for femoropopliteal artery disease in Kanagawa
Acronym	Landmark Registry
Scientific Title	Evaluation of clinical outcome after endovascular therapy for femoropopliteal artery disease in Kanagawa
Scientific Title:Acronym	Landmark Registry
Region	Japan

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

Objectives
Narrative objectives1	We will investigate the actual condition of EVT treatment in the femoral popliteal artery lesion, and clarify the patient's background factors, treatment content, treatment results, and factors that influence outcomes in a multicenter anterior-posterior observational study.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary patency
Key secondary outcomes	TLR: target lesion revascularization MACLE: MACE(major adverse cardiovascular event)+MALE(major adverse limb event)

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	(1) Patients with stenotic or arteriosclerosis obliterans with superficial femoral artery lesions (Rutherford classification 2-6). However, acute (within 7 days) and subacute (within 1 month) lower limb ischemia cases are excluded. (2) Age: 20 years or older (at the time of EVT treatment for femoral popliteal artery lesions) (3)Gender: No matter (4) Patients who can be observed for at least 12 months after EVT (5)Patients who underwent EVT for femoral popliteal artery lesions between July 1, 2017 and June 30, 2020
Key exclusion criteria	(1)Patients who are bleeding or have a tendency to bleed (Hemophilia, capillary fragility, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract bleeding, hemoptysis, etc.) (2)Pregnant women or patients who may be pregnant (3)Patients with acute / subacute lower limb ischemia (4) Patients with a life expectancy of 1 year or less (5)Patients who have difficulty in going to the hospital due to referral from a distance
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Shinsuke Middle name Last name Mori
Organization	Saiseikai Yokohama City Eastern Hospital
Division name	Cardiology
Zip code	230-8765
Address	3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL	045-576-3000
Email	hello_morisun@yahoo.co.jp

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Mori
Organization	Saiseikai Yokohama City Eastern Hospital
Division name	Cardiology
Zip code	230-8765
Address	3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL	045-576-3000
Homepage URL
Email	hello_morisun@yahoo.co.jp

Sponsor
Institute	Saiseikai Yokohama City Eastern Hospital
Institute
Department

Funding Source
Organization	Saiseikai Yokohama City Eastern Hospital
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	Saiseikai Yokohama City Eastern Hospital Ethics Committee
Address	3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
Tel	045-576-3000
Email	kenkyubango@tobu.saiseikai.or.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	2021 Year 11 Month 05 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	1378
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 11 Month 16 Day
Date of IRB	2020 Year 03 Month 26 Day
Anticipated trial start date	2020 Year 03 Month 26 Day
Last follow-up date	2025 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter retrospective observational study

Management information
Registered date	2021 Year 11 Month 05 Day
Last modified on	2021 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050730