UMIN-CTR Clinical Trial

Basic information
Public title	Long term outcome of Endovascular therapy for PAD with intermittent claudication observational prospective multicenter Registry
Acronym	ASHIMORI IC REGISTRY
Scientific Title	Long term outcome of Endovascular therapy for PAD with intermittent claudication observational prospective multicenter Registry
Scientific Title:Acronym	ASHIMORI IC REGISTRY
Region	Japan

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

Objectives
Narrative objectives1	To evalutate the outcome 12 months after Endovascular Treatment(EVT) for PAD patients with claudication. Outcomes are efficacy and safty of EVT and, the efficary includes the patency of index lesion and the change of leg symptoms. We investigate long term outcome 3years after EVT.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary patency rate of target vessel 12 months after EVT
Key secondary outcomes	Improvement of leg symptom 12 months after EVT. Major adverse events (MAE) occurring within 3years after index treatment. MAE is defined as death, myocardial infarction (Q-wave and non-Q-wave), stroke, TVR, or major amputation of index limb Improvement of leg symptom assessed by 6 minutes walking test The change in femoral and the below-knee circumference

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients diagnosed with PAD 2)Patients aged 20 years or older when providing consent 3)Patients providing written consent indicating understanding of and agreement to participate in the study, and willing to undergo follow up at 1, 2, and 3 years after index treatment 4)Patients with an index limb ABI equal to or lower than 0.9, or definite diagnosis of PAD in accordance with ACCF/AHA guidelines if ABI is greater than 0.9. 5)Patients have symptoms including claudication and rest leg pain.
Key exclusion criteria	1)Terminally ill patients expected to live less than one year EVT 2)Patients with ischemic ulcer or gangreen 3)Patients with untreated coagulation or significant bleeding disorders and patients unable to receive anticoagulation or antiplatelet treatment 4)Patients who are or may be pregnant or lactating 5)Patients whose treatment side leg has already been amputated above the ankle 6)to participate in other clinical trials that could possible affect the scientific validity of this study
Target sample size	600

Research contact person
Last name of lead principal investigator	1st name Hiroshi Middle name Last name Ito
Organization	Okayama University
Division name	Department of Cardiovaclar medicine
Zip code	700-8558
Address	2-5-2 SHIKATACHO KITAKU OKAYAMA CITY
TEL	086-235-7351
Email	hiromail1979@yahoo.co.jp

Public contact
1st name of contact person	1st name Hironobu Middle name Last name Toda
Organization	Okayama University
Division name	Department of Cardiovaclar medicine
Zip code	700-8558
Address	2-5-2 SHIKATACHO KITAKU OKAYAMA CITY
TEL	086-235-7351
Homepage URL
Email	hiromail1979@yahoo.co.jp

Sponsor
Institute	Okayama University Department of Cardiovasclar medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikatatyo Kitaku Okayama City
Tel	086-235-6938
Email	mae6605@adm.okayama-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	2015 Year 09 Month 28 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	No longer recruiting
Date of protocol fixation	2015 Year 09 Month 28 Day
Date of IRB	2015 Year 09 Month 29 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is prospective cohort study.We investigate patients performed EVT from Jan, 2016 to Mar 2021.

Management information
Registered date	2015 Year 08 Month 21 Day
Last modified on	2019 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021693