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Korean Multicenter Registry of EPIC stent for Iliac Artery Disease: (K-EPIC Registry)

Not Applicable
Completed
Conditions
Diseases of the circulatory system
Registration Number
KCT0002956
Lead Sponsor
Yonsei University Health System, Severance Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
150
Inclusion Criteria

1) Age 19 years of older
2) Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4)
3) Iliac artery lesions with stenosis > 50%
4) ABI <0.9
5) Patents treated with EPIC stent for femoropopliteal artery disease
6) Patients with signed informed consent

Exclusion Criteria

1) Acute critical limb ischemia
2) Severe critical limb ischemia (Rutherford category 5 or 6)
3) Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin,
clopidogrel, cilostazol, or contrast agents
4) In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to
the enrollment)
5) Bypass graft lesions
6) Age > 85 years
7) Severe hepatic dysfunction (> 3 times normal reference values)
8) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9) LVEF < 40% or clinically overt congestive heart failure
10) Pregnant women or women with potential childbearing
11) Life expectancy <1 year due to comorbidity
12) Untreated proximal inflow disease of aorta or the ipsilateral iliac arteries (more than 50%
stenosis or occlusion)

Study & Design

Study Type
Observational Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary patency
Secondary Outcome Measures
NameTimeMethod
Target lesion revascularization rate;Stent fracture rate;Quality of life by standardized questionnaires
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