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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010071
Receipt No. R000011789
Scientific Title Drug Eluting stent implantation vs BAre metal sTEnt implantation in treatment of SFA
Date of disclosure of the study information 2013/02/18
Last modified on 2019/02/25

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Basic information
Public title Drug Eluting stent implantation vs BAre metal sTEnt implantation in treatment of SFA
Acronym DEBATE in SFA
Scientific Title Drug Eluting stent implantation vs BAre metal sTEnt implantation in treatment of SFA
Scientific Title:Acronym DEBATE in SFA
Region
Japan

Condition
Condition Patient with Peripheral Artery Disease
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of treatment of Drug eluting stent or Bare metal stent with cilostazol for femoropopliteal artery lesions
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major adverse Lower limb events
(major or minor amputation, progression to bypass surgery, repeated revascularization, stent thrombosis,death related Limb events,bleeding)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1.Drug eluting stent group: Treatment with ticlopidine hydrochloride 200 mg/day BID (morning and evening) or clopidgrel 75mg/day and aspirin at 100 mg/day will be started 3 to 7 days prior to EVT and continued until the end of the 2-year follow-up period.
Interventions/Control_2 2.Nitinol stent and Non-cilostazol group: Treatment with aspirin 100 mg/day will be started 3 to 7 days prior to EVT and continued until the end of the 2-year follow-up period.
And oral treatment with ticlopidine hydrochloride 200 mg/day BID (morning and evening) will be started 3 to 7 days prior to EVT and continued until 4 weeks after EVT (only stenting).
Interventions/Control_3 3.Nitinol stent and Cilostazol group: Treatment with cilostazol 200 mg/day BID (morning and evening) and aspirin at 100 mg/day will be started 3 to 7 days prior to EVT and continued until the end of the 2-year follow-up period.
If dose reduction of cilostazol is required due to adverse drug reactions such as headache, the dosage may be reduced to 100 mg/day BID.
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
99 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria
Patient criteria
Patients who meet all of the following criteria will be included in the study:
1. Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area*
(Rutherford classification 2-4) (see Appendix 1)
*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 2 years after surgery
(Patients who can undergo follow-up angiography 2 years after surgery)
Lesion criteria
1. Angiographically-confirmed new significant superficial femoral artery stenosis or occlusive lesions. The inferior and superior poles of the superficial femoral artery are defined as the overlap with the bone in the adductor canal in the upper part of the femur, and the origin of the bifurcation, respectively.
2. At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included.
Key exclusion criteria 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.Patients with congestive cardiac failure (NYHA III or IV or EF<30%)
3.Patients implanted a drug-eluting stent (DES) within 3months
4.patients with a history of serious adverse reaction such as leukopenia, hepatic dysfunction, or renal dysfunction, or hypersensitivity to any component of the study drug.
5.Pregnant or potentially pregnant women
6.Patients with acute lower limb ischemia
7.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)
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Miyashita
Organization Shinshu university hospital
Division name department of cardiology
Zip code
Address 3-1-1 Asahi Matsumoto-shi
TEL 0263-37-3486
Email ybm1965@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Miura
Organization Shinshu university hospital
Division name cardiology
Zip code
Address 3-1-1 Asahi Matsumoto-shi
TEL 0263-37-3486
Homepage URL
Email miuramen10miuramen@yahoo.co.jp

Sponsor
Institute Shinshu university hospital
Institute
Department

Funding Source
Organization Shinshu university hospital
Organization
Division
Category of Funding Organization
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
2013 Year 02 Month 18 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 01 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 18 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011789

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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