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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033050
Receipt No. R000037684
Scientific Title The effect of endovascular therap y on the exercise tolerance of peri pheral arterial disease
Date of disclosure of the study information 2018/06/20
Last modified on 2018/06/19

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Basic information
Public title The effect of endovascular therap y on the exercise tolerance of peri pheral arterial disease
Acronym PAD-CPX study
Scientific Title The effect of endovascular therap y on the exercise tolerance of peri pheral arterial disease
Scientific Title:Acronym PAD-CPX study
Region
Japan

Condition
Condition Peripheral arterial disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The exercise capacity of peripher al arterial disease is limited for th e flow limit to the lower extremiti es. The aim of ths study is to inve stigate the effect of the endovascu lar therapy on exercise tolerance of peripheral arterial disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The exercise tolerance (AT, peak VO2, 6MWD)
We evaluate these parameters bef ore EVT, immedeately after EVT a nd 3 months after EVT.
Key secondary outcomes The subjective symptoms (Rutherf ord class)
The periperal circulation index (A BI, SPP)
Other index of the cardiopulmona ry exercise test.
Cardiac function.

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
90 years-old >=
Gender Male and Female
Key inclusion criteria Symptomatic PAD patient (>=Rutherford : Category 2) refractory to t he standard non-invasive treatme nt (exercise and/or medical treat ment)
Key exclusion criteria Clinical Lim ischemia
people who do not bicycle Severe coronary artery disease Severe LV dysfunction
Severe arrhythmia
Pregnancy
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeyuki Watanabe
Organization Mito Kyodo General Hospital
Division name Cardiology Department
Zip code
Address 3-2-7 Miya-Machi Mito Japan
TEL 029-231-2371
Email watanabe.s.gn@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Toyama
Organization Mito Kyodo General Hospital
Division name Cardiology Department
Zip code
Address 3-2-7 Miya-Machi Mito Japan
TEL 029-231-2371
Homepage URL
Email mt@mail1.accsnet.ne.jp

Sponsor
Institute Mito Kyodo General Hospital Cardiology Department
Institute
Department

Funding Source
Organization Mito Kyodo General Hospital Cardiology Department
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
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 筑波大学附属病院水戸地域医療教育センター・水戸協同病院(茨城県)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Before the start

Management information
Registered date
2018 Year 06 Month 19 Day
Last modified on
2018 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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