Popliteal Artery Disease
Conditions
Keywords
Popliteal artery disease, drug-eluting balloon, angioplasty
Brief summary
* Prospective, multi-center, single-arm registry study * A total of 100 subjects with isolated popliteal artery lesions according to inclusion and exclusion criteria will be enrolled. * All popliteal artery lesions will be treated with drug-eluting balloon (In.PACT Admiral, Medtronic). • Atherectomy or use of bare nitinol stent in combination with drug-eluting balloon is allowed • Patients will be followed clinically for 12 months after the procedure. * Imaging study (Duplex ultrasound, CT angiography or catheter angiography) follow-up will be performed at 12 months.
Interventions
DEVICEdrug-eluting balloon (In.PACT Admiral, Medtronic)
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 or older 2. Symptomatic peripheral artery disease: * Moderate or severe claudication (Rutherford category 2 or 3) * Critical limb ischemia (Rutherford category 4 or 5) 3. Atherosclerotic popliteal artery disease (stenosis \> 50%) 4. Patients with signed informed consent
Exclusion criteria
1. Acute critical limb ischemia 2. Severe critical limb ischemia (Rutherford category 6) 3. Involvement of SFA disease with stenosis 4. Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk). 5. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent 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. Previous bypass surgery or stenting for the target popliteal artery 13. Untreated inflow disease of the ipsilateral pelvic or femoropopliteal 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% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel revascularization rate | 12 months | frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel |
Countries
South Korea
Outcome results
None listed