UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001036
Receipt number R000001242
Scientific Title Cilostazol Reduces Restenosis Following Endovascular Therapy in Patients with Femoro-popliteal Lesions
Date of disclosure of the study information 2008/04/01
Last modified on 2008/04/04 19:07:59

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Basic information

Public title

Cilostazol Reduces Restenosis Following Endovascular Therapy in Patients with Femoro-popliteal
Lesions

Acronym

Cilostudy

Scientific Title

Cilostazol Reduces Restenosis Following Endovascular Therapy in Patients with Femoro-popliteal
Lesions

Scientific Title:Acronym

Cilostudy

Region

Japan


Condition

Condition

Patients who underwent endovascular therapy for symptomatic de
novo FP lesions

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prospectively investigate whether cilostazol reduces restenosis following successful EVT for
de novo FP lesions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

patency

Key secondary outcomes

1) Target lesion revascularization
2) All events included restenosis, amputation and death from any
causes


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Aspirine 100mg/day, Cilostazol (200mg/day)

Interventions/Control_2

Aspirine 100mg/day, Ticlopidine (200mg/day)

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

1) de novo FP lesions of > 50 percent diameter
stenosis, occlusion without inflow lesions (the aorto-Iliac or common femoral artery) and with
outflow lesions of the below-the-knee arteries better than one vessel run off as evaluated by
angiography
2) patients with symptomatic PAD with
claudication (Fontaine 2), intractable rest pain (Fonatine 3) and non- healing ulcer (Fontaine 4) due
to FP lesions

Key exclusion criteria

acute onset critical limb ischemia, previous bypass
surgery or angioplasty for the FP lesions, presence of untreated pelvic lesions, and known
intolerance to the medication or contrast agents

Target sample size

127


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Iida

Organization

Kansai Rosai Hospital

Division name

Cardiovascular Division

Zip code


Address

3-1-69, Inabaso, Amagasaki city, Hyogo

TEL

06-6416-1221

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kansai Rosai Hospital

Division name

Cardiovascular Division

Zip code


Address


TEL


Homepage URL


Email

osa-iida@nifty.com


Sponsor or person

Institute

Kansai Rosai 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

2008 Year 04 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

Completed

Date of protocol fixation

2004 Year 02 Month 10 Day

Date of IRB


Anticipated trial start date

2004 Year 03 Month 01 Day

Last follow-up date

2007 Year 12 Month 01 Day

Date of closure to data entry

2007 Year 12 Month 01 Day

Date trial data considered complete

2007 Year 12 Month 01 Day

Date analysis concluded

2007 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 02 Month 16 Day

Last modified on

2008 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001242


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name