UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012565
Receipt number R000014698
Scientific Title Strut Coverage After Paclitaxel-Eluting Stent implantation Compared with Bare Metal Stent Implantation in the Superficial Femoral Artery: Optical Frequency Domain Imaging Study
Date of disclosure of the study information 2014/02/01
Last modified on 2017/07/11 11:44:52

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Basic information

Public title

Strut Coverage After Paclitaxel-Eluting Stent implantation Compared with Bare Metal Stent Implantation in the Superficial Femoral Artery: Optical Frequency Domain Imaging Study

Acronym

Strut Coverage After Paclitaxel-Eluting Stent implantation Compared with Bare Metal Stent Implantation in the Superficial Femoral Artery: Optical Frequency Domain Imaging Study

Scientific Title

Strut Coverage After Paclitaxel-Eluting Stent implantation Compared with Bare Metal Stent Implantation in the Superficial Femoral Artery: Optical Frequency Domain Imaging Study

Scientific Title:Acronym

Strut Coverage After Paclitaxel-Eluting Stent implantation Compared with Bare Metal Stent Implantation in the Superficial Femoral Artery: Optical Frequency Domain Imaging Study

Region

Japan


Condition

Condition

Peripheral Artery Disease (PAD)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the detailed vascular responses to different stent types in the superficial femoral artery lesions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The percentage of uncovered stent struts 6 months after stent implantation

Key secondary outcomes

Neointimal volume 6 months after 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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bare-metal nitinol stent implantation for the superficial femoral artery lesion

Interventions/Control_2

Paclitaxel-eluting nitinol stent implantation for the superficial femoral artery lesion

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

Patients planned endovascular therapy with self-expanding stent for the de novo superficial femoral artery lesions (less than 15cm) in Hyogo College of Medicine

Key exclusion criteria

1)Lesions with previous stent implantation
2)Lesions with previous FP-bypass
3)Acute or subacute limb ischemia
4)Patients without tolerance for antiplatelet agents
5)Patients without written informed consent

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tohru Masuyama

Organization

Hyogo College of Medicine

Division name

Cardiovascular Division

Zip code


Address

1-1 Mukogawa-cho, Nishinomiya-city, Hyogo, 6638501, Japan

TEL

0798456553

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

Cardiovascular Division

Zip code


Address

1-1 Mukogawa-cho, Nishinomiya-city, Hyogo, 6638501, Japan

TEL

0798456553

Homepage URL


Email

hpxkg043@ybb.ne.jp


Sponsor or person

Institute

Cardiovascular Division, Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Cardiovascular Division, 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

兵庫医科大学病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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 12 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 10 Day

Last follow-up date

2014 Year 12 Month 09 Day

Date of closure to data entry

2014 Year 12 Month 31 Day

Date trial data considered complete

2014 Year 12 Month 31 Day

Date analysis concluded

2014 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 12 Month 12 Day

Last modified on

2017 Year 07 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014698


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name