Iliac Artery Disease
Conditions
Keywords
Peripheral artery disease, Iliac artery, nitinol stent, restenosis
Brief summary
* Prospective, single-arm, multi-center registry study * A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion criteria will be included. * Patients will be followed clinically for 12 months after the procedure. * Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months. * Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months. * Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)
Interventions
DEVICEEpic stent (Boston Scientific)
Sponsors
Yonsei University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
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. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 12 months | Absence of restenosis \>50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion revascularization rate | 12 months |
| Stent fracture rate | 12 months |
| Quality of life by standardized questionnaires | 12 months |
Countries
South Korea
Outcome results
None listed