UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of Stent Diameter on Vascular Response After Self-expanding Paclitaxel-eluting Stent Implantation in the Superficial Femoral Artery: An Optical Frequency Domain Imaging Study
Title of the study (Brief title)	Optimal Diameter of Self-expanding Paclitaxel-eluting Stent in the Superficial Femoral Artery
Region	Japan

Condition
Condition	Peripheral Artery Disease
Classification by specialty	Cardiology Vascular surgery Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyse the optimal stent diameter of self-expanding paclitaxel-eluting stent in the superficial femoral artery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lumen volume 6 months after self-expanding paclitaxel-eluting stent implantation
Key secondary outcomes	Neointimal volume 6 months after self-expanding paclitaxel-eluting stent implantation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	paclitaxel-eluting stent implantation with the diameter of 6mm
Interventions/Control_2	paclitaxel-eluting stent implantation with the diameter of 8mm
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	Not applicable
Gender	Male and Female
Key inclusion criteria	PAD patients with isolated SFA lesion (length less than 150mm)
Key exclusion criteria	Patients with in-flow or out-flow disease Restenotic lesions
Target sample size	20

Research contact person
Name of lead principal investigator	Masaharu Ishihara
Organization	Hyogo College of Medicine
Division name	Division of Coronary Heart Disease
Address	1-1 Mukogawa-cho, Nishinomiya-city, Hyogo, 6638501, Japan
TEL	0798456553
Email	hpxkg043@ybb.ne.jp

Public contact
Name of contact person	Kojiro Miki
Organization	Hyogo College of Medicine
Division name	Cardiovascular Division
Address	1-1 Mukogawa-cho, Nishinomiya-city, Hyogo, 6638501, Japan
TEL	0798456553
Homepage URL
Email	hpxkg043@ybb.ne.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Cook Japan
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 21 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 21 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=R000017996