UMIN-CTR Clinical Trial

Public title

A study to evaluate the effect of cilostazol after endovascular therapy for SFA lesions

Acronym

A study to evaluate the effect of cilostazol after endovascular therapy for SFA lesions

Scientific Title

A study to evaluate the effect of cilostazol after endovascular therapy for SFA lesions

Scientific Title:Acronym

A study to evaluate the effect of cilostazol after endovascular therapy for SFA lesions

Region

Japan

Condition

Peripheral arterial disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine whether cilostazol prevents restenosis following endovascular therapy for SFA lesions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Angiographic restenosis rate (12 months)(-1month+1month)

Key secondary outcomes

Patency rate, ABPI, Cardiovascular events (death, MI, stroke), Lower limb vascular events, all cause mortality

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Aspirin group (aspirin 100mg/day)

Interventions/Control_2

Cilostazol group
(cilostazol 100-200mg/day BID)

Interventions/Control_3

Cilostazol/Clopidogrel group
(cilostazol 100-200mg/day BID, clopidogrel 75mg/day)
In every group, oral treatment with aspirin 100mg/day and clopidogrel 75mg/day must be started 3-7 days prior to EVT, and continued until 60 days after EVT.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patient criteria
Patients who meet all of the following criteria will be included in the study:
1. Chronic arteriosclerosis obliterans afflicting the SFA area*
(Rutherford classification 2-4)
*Except for patients with acute (within 1 week after onset)/subacute (2 weeks to 1 month after onset) lower limb ischemia
2. Age: 20 years or older at the time of consent
3. Gender: Male or female
4. Patients who can be monitored for at least 24 months after surgery

Lesion criteria
1. New significant superficial femoral artery stenosis or occlusive lesions.
2. At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included.
In addition, patients with bilateral lesions or aorta-iliac artery lesions may be included.
3. Occlusive lesions may be included.

Key exclusion criteria

Patient criteria
Patients who meet any of the following criteria should be excluded from the study:
1.Patients with or at risk of hemorrhagic complications or patients with bleeding* tendency
*Bleeding such as hemophilia, capillary fragility, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage may be aggravated.
2.Pregnant or potentially pregnant women
3.Patients with acute lower limb ischemia
4. Patients who are not eligible for the study in the opinion of the attending physician.

Lesion criteria
Lesions that meet any of the following criteria should be excluded from the study:
1.Remnant inflow (aorta-iliac artery lesion)
2.Severe calcification (lesions not expected to be appropriately expanded)
3.No arterial runoff below the knee

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Yasunari Sakamoto

Organization

Saiseikai yokohama city eastern hospital

Division name

cardiology

Zip code

Address

3-6-1 Shimosueyoshi Tsurumi-ku Yokohama Kanagawa

TEL

045-576-3000

Email

Name of contact person

1st name
Middle name
Last name	Yasunari Sakamoto

Organization

Saiseikai yokohama city eastern hospital

Division name

cardiology

Zip code

Address

TEL

Homepage URL

Email

y_sakamoto@tobu.saiseikai.or.jp

Institute

Saiseikai yokohama city eastern hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

07

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2013

Year

07

Month

04

Day

Date of IRB

Anticipated trial start date

2013

Year

08

Month

01

Day

Last follow-up date

2016

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

07

Month

06

Day

Last modified on

2013

Year

07

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013041