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
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
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
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
