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
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
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
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
