Critical Limb Ischemia (Rutherford Category 4 or 5), Moderate or Severe Claudication (Rutherford Category 2 or 3), Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions
Conditions
Keywords
Peripheral artery disease, femoropopliteal, drug-eluting stent, restenosis
Brief summary
* Prospective, multi-center single-arm observational study * A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included. * Patients will be followed clinically for 24 months after the procedure. * An imaging study (duplex ultrasound, CT or catheter-based angiography) follow-up according to participating hospital's protocol will be performed at 12 months. * Ankle-brachial index, symptom status and presence of stent fracture will be evaluated at 12 months.
Detailed description
• Prospective, multi-center single-arm observational study Screening (day 0): 1. Medical history and demography of the patient reviewed 2. Inclusion/exclusion eligibility will be checked 3. Physical examination (Height, weight) 4. Laboratory test * BUN, eGFR, Cr. * Hb, WBC, platelet * Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C) 5. Ankle-brachial index 6. Imaging study (CT/MR angiography, Doppler ultrasound, or catheter angiography) 7. Medication Enrollment (day 0): 1\) Written consent Post PTA (Day 1 \ 3): 1. Adverse event 2. Ankle-brachial index 3. Laboratory test: * BUN, eGFR, Cr. * Hb, WBC, platelet 4. Concomitant medication Regular Follow-up Visits Visit 1 (post-PTA 30±14 days) 1\) Symptom: Rutherford class 2) Laboratory test: * BUN, eGFR, Cr. * Hb, WBC, platelet 3) Concomitant medication 4) Adverse event Visit 2 (post-PTA 6 months ± 30 days) 1. Symptoms: Rutherford class 2. Ankle-brachial index 3. Concomitant medication 4. Adverse event Visit 3 (post-PTA 12 months ± 60 days) <!-- --> 1. Symptoms: Rutherford class 2. Ankle-brachial index 3. Duplex ultrasound, CT, or catheter angiography 4. Biplane radiograph of femur for evaluation of stent fracture 5. Laboratory test * BUN, eGFR, Cr. * Hb, WBC, platelet * Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C) 6)Concomitant medication 7) Adverse event Visit4 (post-PTA 24 months ± 60 days) 1. Symptom: Rutherford category 2. Adverse events
Interventions
Implantation of Eluvia stent
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 before treatment 5. Patents treated with ELUVIA 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 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 |
|---|---|---|
| Clinical patency | at 24 months | Freedom from symptom worsening, as indicated by an increase in Rutherford category accompanied by a ≥ 0.15 decrease in ABI or \> 50% restenosis on imaging studies at 24 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle-brachial index | at 12 and 24 months | Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm |
| Ruthford category | at 12 and 24 months | Rutherford category - symptom status by Rutherford category |
| target lesion revascularization | at 12 and 24 months | Target lesion revascularization - accumulative rate of repeat interventions or surgery for the treatment of symptomatic restenosis (\>50% stenosis) in the target lesion |
| stent fracture rate | at 12 and 24 months | stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections |
Countries
South Korea
Outcome results
None listed