UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001036
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Kansai Rosai Hospital
Institute
Department

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
URL(English) https://upload.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


Contact us.