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 12 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
Enrollment (day 0): 1\) Written consent Post PTA (Day 1 \ 3): 1. Symptom: Rutherford class 2. Adverse event 3. Ankle-brachial index 4. Laboratory test: - eGFR, Cr, ALT, AST * Hb, WBC, platelet 5. Concomitant medication Regular Follow-up Visits Visit 1 (post-PTA 30±14 days): 1. Symptom: Rutherford class 2. Physical examination 3. Concomitant medication 4. Adverse event 5. Laboratory test: * AC glucose, eGFR, Cr, ALT, AST * Hb, WBC, platelet * Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C) * HbA1c in case of DM * hsCRP Visit 2 (post-PTA 6 months ± 30 days): 1. Symptoms: Rutherford class 2. Physical examination 3. Ankle-brachial index 4. Concomitant medication 5. Adverse event Visit 3 (post-PTA 12 months ± 30 days): (Mandatory) 1. Symptoms: Rutherford class 2. Physical examination 3. Ankle-brachial index 4. Duplex ultrasound, CT, or catheter angiography 5. Concomitant medication 6. Adverse event 7) Biplane radiograph of femur for evaluation of stent fracture 8) Laboratory test: - AC glucose, eGFR, Cr, ALT, AST * Hb, WBC, platelet * Lipid level (total cholesterol, LDL-C,triglyceride, HDL-C) * HbA1c in case of DM * hsCRP
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
* Age 19 years of older * Symptomatic peripheral artery disease: Moderate or severe claudication (Rutherford category 2 or 3) and Critical limb ischemia (Rutherford category 4-5) * Femoropopliteal artery lesions with stenosis \> 50% * ABI \< 0.9 before treatment * Patents treated with ELUVIA stent for femoropopliteal artery disease * Patients with signed informed consent
Exclusion criteria
* Acute critical limb ischemia * Severe critical limb ischemia (Rutherford category 6) * Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents * In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment) * Bypass graft lesions * Age \> 85 years * Severe hepatic dysfunction (\> 3 times normal reference values) * Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis * LVEF \< 40% or clinically overt congestive heart failure * Pregnant women or women with potential childbearing * Life expectancy \<1 year due to comorbidity * Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | at 12 months | Absence of stenosis \>50% by an follow-up imaging study (duplex ultrasound, CT or catheter-based angiography) at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle-brachial index | at 12 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 months | Rutherford category - symptom status by Rutherford category |
| target lesion revascularization | at 12 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 months | stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections |
Countries
South Korea
Outcome results
None listed