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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015100
Receipt No. R000017567
Scientific Title Contemporary Management and Prognosis in Japanese peripheral artery disease patients with endovascular treatment
Date of disclosure of the study information 2014/09/09
Last modified on 2018/05/30

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Basic information
Public title Contemporary Management and Prognosis
in Japanese peripheral artery disease patients with endovascular treatment
Acronym TOMAcode Registry
Scientific Title Contemporary Management and Prognosis
in Japanese peripheral artery disease patients with endovascular treatment
Scientific Title:Acronym TOMAcode Registry
Region
Japan

Condition
Condition Peripheral artery disease
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the comtemporary management, the clinical outcome and predictive value in Japanese peripheral artery disease patients with endovascular treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patients Base:
MACCE;Major Adverse Cardio-CerebroVascular Event(all cause death, myocardial infarction,stroke)
MAE;Major Adverse Event(MACCE,unscheduled major amptation, acute limb ischemia, major limb reintervention)

Limb base:
MALE;Major Adverse Limb Event(unscheduled major amptation, unscheduled major limb reintervention, acute limb ischemia, unscheduled limb endovascular treatment)
Key secondary outcomes 1.safty in endovascular treatment
2.Procedure and lesion success
3.Puncture site complications by hemostasis device use
4.limb reintervention with restenosis
5.limb endovascular treatment with new lesion
6.stent thrombosis in lower limb
7.Bleeding event
8.Aortic event
9.event that requires regular hemodialysis
10.hospitalization with heart failure
11.new diagonosis of malignancy
12.change of limb sympton

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
10 years-old <
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1.patients with endovasculartreatment in the lower limb
2.patients with agreement for study
Key exclusion criteria 1.patients with endovascular treatment for the aneurysm
2.inappro@riate patients determined from study director
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Higashitani
Organization Tokyo Medical University Ibaraki Medical Center
Division name Department of Cardiology
Zip code
Address 3-20-1 Amimachi Chuo Inashikigun Ibaraki
TEL 029-887-1161
Email mhigashi@shi.heart.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Clinical Trials Support Office
Organization Sakakibara Heart Institute
Division name Clinical Trials Support Office
Zip code
Address 3-16-1 asahi-cho Futyu-shi Tokyo
TEL 042-314-3111
Homepage URL
Email tikenjim@shi.heart.or.jp

Sponsor
Institute Tokyo Medical University Ibaraki Medical Center
Institute
Department

Funding Source
Organization Japan Reserch Promotion Society for Cardiovascular disease
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor 1.Japanese Red Cross Musashino Hospital
2.Higashiyamato Hospital
3.Tokyo Rosai Hospital
4.St Luke's International Hospital
5.Itabashi Chuo Medical Center
6.Kasukabe Chuo Medical Center
7.Toranomon Hospital
8.Yamato Seiwa Hospital
9.Kawakita general hospital
10.The Fraternity Memorial Hospital
11.Ohme Municipal General Hospital
12.Medical Hospital of Tokyo Medical and Dental University
13.Nishiarai Heart Center Hospital
14.Chiba Kaihin Municipal Hospital
15.Yokohama City Minato Red Cross Hospital
16.The Cardiovascular Institute
17.Shuuwa General Hospital
18.2. Saitama Prefecture cardiovascular and respiratory center
19.Shioda Memorial Hospital
20.Tokyo Teishin Hospital
21.Gunma University Hospital
22.Nippon Medical School hospital
23.SAISEIKAI central hospital
24.National hospital organization SAITAMA National hospital
25.Yokohama chuo hospital
26.TAKASE clinic
27.Juntendo University Urayasu Hospital
28.Nippon Medical School Musashi Kosugi Hospital
29.ShonanKamakura General Hospital
30.Ota Memorial Hospital
31.Tokyo Medical University Hospital
32.Tokyo Medical University Ibaraki Medical Center
33.SADO General Hospital
34.MITO SAISEIKAI General Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 榊原記念病院 Sakakibara Heart Institute

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2014 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 10 Day
Last follow-up date
2016 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information During the observation period

Management information
Registered date
2014 Year 09 Month 09 Day
Last modified on
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017567

Research Plan
Registered date File name
2016/08/19 Final version 20160431 第5版 研究計画書 TOMA-code Registry.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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