UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Drug Eluting stent implantation vs BAre metal sTEnt implantation in treatment of SFA
Title of the study (Brief title)	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	Yusuke Miyashita
Organization	Shinshu university hospital
Division name	department of cardiology
Address	3-1-1 Asahi Matsumoto-shi
TEL	0263-37-3486
Email	ybm1965@yahoo.co.jp

Public contact
Name of contact person	Takashi Miura
Organization	Shinshu university hospital
Division name	cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011789