UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018614
Receipt number 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 16:27:30

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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 or person

Institute

Saiseikai Yokohama City Eastern Hospital

Institute

Department

Personal name



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

Value
https://center6.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