Femoropopliteal Artery Disease
Conditions
Keywords
Femoropopliteal Artery, Drug-eluting Stent, Endovascular Therapy
Brief summary
* Prospective, randomized, controlled, multi-center study * A total of 220 subjects with long femoropopliteal lesions will be included according to inclusion and exclusion criteria. * Patients will be randomized in a 1:1 manner into long stenting group versus short stenting group. and treated with Zilver PTX for long femoropopliteal lesions * Patients will be followed clinically for 1 year after the procedure. * Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.
Interventions
DEVICELong stenting using drug-eluting stent (Zilver PTX)
Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty
DEVICESpot stenting using drug-eluting stent (Zilver PTX)
Spot stenting by coverage of residual stenosis or flow-limiting dissection with Zilver PTX after balloon angioplasty of long femoropopliteal lesion
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Clinical criteria: 1. Age 19 years of older 2. Symptomatic peripheral artery disease: 1. Moderate or severe claudication (Rutherford category 2 or 3) 2. Critical limb ischemia (Rutherford category 4 or 5) 3. Patients with signed informed consent * Anatomical criteria: 1. Target lesion length ≥150 mm by angiographic estimation 2. Stenosis of more than 50% in femoropopliteal artery 3. At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.
Exclusion criteria
* A. Clinical criteria 1. Acute critical limb ischemia 2. Severe critical limb ischemia (Rutherford category 6) 3. Major bleeding history within prior 2 months 4. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents 5. Age \> 85 years 6. Severe hepatic dysfunction (\> 3 times normal reference values) 7. Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl 8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis 9. LVEF(left ventricular ejection fraction) \<40% or clinically overt congestive heart failure 10. Pregnant women or women with potential childbearing 11. Life expectancy \<1 year due to comorbidity * Angiographic criteria 1. Previous bypass surgery or stenting of the superficial femoral artery 2. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50%stenosis or or occlusion 3. Popliteal artery stenosis \>50% at P2 or P3 segment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate | 12 months | Absence of restenosis \>50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel revascularization rate | 12 months | repeat intervention or surgical treatment due to loss of patency at the target vessel |
Countries
South Korea
Outcome results
None listed