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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018614
Receipt No. R000021542
Scientific Title Clinical impact of post-procedural fractional flow reserve on future restenosis in superficial femoral artery disease
Date of disclosure of the study information 2015/08/09
Last modified on 2015/08/10

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Basic information
Public title Clinical impact of post-procedural fractional flow reserve on future restenosis in superficial femoral artery disease
Acronym post-procedural fractional flow reserve for superficial femoral aretery disease and restenosis
Scientific Title Clinical impact of post-procedural fractional flow reserve on future restenosis in superficial femoral artery disease
Scientific Title:Acronym post-procedural fractional flow reserve for superficial femoral aretery disease and restenosis
Region
Japan

Condition
Condition superficial femoral artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical impact of post endovascular therapy fractional flow reserve for superficial femoral artery disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes restenosis rate
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria successful endovascular therapy for superficial femoral artery disease
Key exclusion criteria patients with aneurysm or stenosis at aorta or iliac artery, patients with congestive heart failure (New York Heart Association functional class 3-4), patients with severe pulmonary hypertension as evidenced by ultrasound cardiography, patients with no run-off vessel.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kobayashi
Organization Saiseikai Yokohama-city Eastern Hospital
Division name Cardiology
Zip code
Address 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, JAPAN
TEL +81-45-576-3000
Email ovation17@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Norihiro Kobayashi
Organization Saiseikai Yokohama City Eastern Hospital
Division name Cardiology
Zip code
Address 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, JAPAN
TEL +81-45-576-3000
Homepage URL
Email ovation17@gmail.com

Sponsor
Institute Saiseikai Yokohama City Eastern Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 09 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 Completed
Date of protocol fixation
2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 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 To evaluate the clinical impact of post endovascular therapy fractional flow reserve for superficial femoral artery disease.
Singlecenter, prospective, observational study. We perform FFR measurement after endovascula therapy for superficial femoral artery disease.

Management information
Registered date
2015 Year 08 Month 09 Day
Last modified on
2015 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021542

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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