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Drug Eluting stent implantation vs BAre metal sTEnt implantation in treatment of SFA

Not Applicable
Conditions
Patient with Peripheral Artery Disease
Registration Number
JPRN-UMIN000010071
Lead Sponsor
Shinshu university hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
360
Inclusion Criteria

Not provided

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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Major adverse Lower limb events (major or minor amputation, progression to bypass surgery, repeated revascularization, stent thrombosis,death related Limb events,bleeding)
Secondary Outcome Measures
NameTimeMethod
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