UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034819
Receipt number R000039707
Scientific Title Impact of IVUS-derived Vessel Size on Long-term Outcomes after Stent Implantation in Femoropopliteal Artery Lesions
Date of disclosure of the study information 2018/11/11
Last modified on 2019/05/13 20:29:29

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Basic information

Public title

Impact of IVUS-derived Vessel Size on Long-term Outcomes after Stent Implantation in Femoropopliteal Artery Lesions

Acronym

IVUS findings predicting long-term stent patency

Scientific Title

Impact of IVUS-derived Vessel Size on Long-term Outcomes after Stent Implantation in Femoropopliteal Artery Lesions

Scientific Title:Acronym

IVUS findings predicting long-term stent patency

Region

Japan


Condition

Condition

peripheral artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to identify intravascular ultrasound (IVUS) findings that can predict long-term stent patency after endovascular therapy (EVT) in femoropopliteal (FP) lesions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

primary patency at 24 months

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

Rutherford categories 2-5
de novo FP lesions

Key exclusion criteria

Rutherford categories 1
restenotic lesions

Target sample size

274


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kojiro Miki

Organization

Hyogo College of Medicine

Division name

Division of Cardiovascular Medicine and Coronary Heart Disease

Zip code


Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8131, Japan

TEL

0798-65-6553

Email

hpxkg043@ybb.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kojiro Miki

Organization

Hyogo College of Medicine

Division name

Division of Cardiovascular Medicine and Coronary Heart Disease

Zip code


Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8131, Japan

TEL

0798-65-6553

Homepage URL


Email

hpxkg043@ybb.ne.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Other

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

2018 Year 11 Month 11 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

274

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

No longer recruiting

Date of protocol fixation

2010 Year 01 Month 01 Day

Date of IRB

2018 Year 09 Month 01 Day

Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A total of 335 de novo FP lesions in 274 patients who underwent successful EVT with self-expanding stents using IVUS at Hyogo College of Medicine were reviewed. The primary outcome was primary patency at 24 months.


Management information

Registered date

2018 Year 11 Month 08 Day

Last modified on

2019 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039707


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name