UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010071 |
|---|---|
| Receipt number | 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 08:37:56 |
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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
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
miuramen10miuramen@yahoo.co.jp
Sponsor or person
Institute
Shinshu university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011789
