UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033050
Receipt number 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 2023/06/29 07:58:11

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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 Shigeyuki
Middle name
Last name Watanabe

Organization

Mito Kyodo General Hospital

Division name

Cardiology Department

Zip code

310-0015

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 Masahiro
Middle name
Last name Toyama

Organization

Mito Kyodo General Hospital

Division name

Cardiology Department

Zip code

301--0015

Address

3-2-7 Miya-Machi Mito Japan

TEL

029-231-2371

Homepage URL


Email

mt@mail1.accsnet.ne.jp


Sponsor or person

Institute

Mito Kyodo General Hospital Cardiology Department

Institute

Department

Personal name



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

Mito Kyodo General Hospital

Address

3-2-7 Miya-Machi Mito Japan

Tel

029-231-2371

Email

mt@mail1.accsnet.ne.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

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

Terminated

Date of protocol fixation

2018 Year 05 Month 07 Day

Date of IRB

2018 Year 06 Month 30 Day

Anticipated trial start date

2018 Year 07 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Terminated


Management information

Registered date

2018 Year 06 Month 19 Day

Last modified on

2023 Year 06 Month 29 Day



Link to view the page

Value
https://center6.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