Femoropopliteal Artery Disease
Conditions
Keywords
Peripheral Artery Disease, Femoropopliteal Artery, Nitinol Stent, Restenosis
Brief summary
* Prospective, single-arm, multi-center registry study * A total of 150 subjects with femoropopliteal 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
DEVICEinnova 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 4-5) 3. Femoropopliteal 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 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 the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate | 12 months after the index procedure | Absence of restenosis \>50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion revascularization rate | 12 months | — |
| Stent fracture rate | 12 months | — |
| Quality of life | 12 months | Quality of life by standardized questionnaires |
Countries
South Korea
Outcome results
None listed