UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015100
Receipt number 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 14:23:22

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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 or person

Institute

Tokyo Medical University Ibaraki Medical Center

Institute

Department

Personal name



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

Value
https://center6.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