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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023642
Receipt No. R000027226
Scientific Title Optimal Sizing of Self-expanding Paclitaxel-eluting Stent for the Superficial Femoral Artery Lesion
Date of disclosure of the study information 2016/11/01
Last modified on 2017/07/11

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Basic information
Public title Optimal Sizing of Self-expanding Paclitaxel-eluting Stent for the Superficial Femoral Artery Lesion
Acronym Optimal Sizing of Self-expanding Paclitaxel-eluting Stent for the Superficial Femoral Artery Lesion
Scientific Title Optimal Sizing of Self-expanding Paclitaxel-eluting Stent for the Superficial Femoral Artery Lesion
Scientific Title:Acronym Optimal Sizing of Self-expanding Paclitaxel-eluting Stent for the Superficial Femoral Artery Lesion
Region
Japan

Condition
Condition Arteriosclerosis Obliterans: ASO
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the optimal stent diameter in the treatment for the superficial femoral artery lesion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lumen area assessed by OFDI at 6-month follow-up
Key secondary outcomes Minimum lumen diameter assessed by angiography at 6-month follow-up.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Implantation of stent with a 1mm larger diameter than the reference vessel
Interventions/Control_2 Implantation of stent with a 2mm larger diameter than the reference vessel
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria De novo superficial femoral artery lesion
Key exclusion criteria History of previous bypass surgery or previous stenting in the target lesion
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Ishihara
Organization Hyogo College of Medicine
Division name Division of Cardiovascular Medicine and Coronary Heart Disease
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL 0798-45-6553
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, 663-8501, Japan
TEL 0798-45-6553
Homepage URL
Email hpxkg043@ybb.ne.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
2016 Year 11 Month 01 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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

Management information
Registered date
2016 Year 08 Month 16 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027226

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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