Femolo-popliteal artery disease
Conditions
Interventions
paclitaxel-eluting balloon
conventional uncoated balloon
Sponsors
Kurashiki Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (General) 1. Age >= 20 years 2. Patients or patients' legal representatives have given written informed consent. 3. Patients understand and agree to the study duration and required follow-up visits. 4. Patients are definitely diagnosed with ischemic symptomatic arterial disease in femoral-popliteal arteries according to Rutherford class 1, 2, 3, or 4. 5. Life expectancy > 1 year in the investigator's opinion (Anatomic) 1. Target vessel is located in the superficial femoral artery and/or proximal popliteal artery above the knee. 2. Target lesion is single solitary or adjacent multiple, de novo or restenotic lesion with >=70% diameter stenosis by visual estimate and cumulative lesion length <=15cm. 3. Adjacent multiple lesions are treated as a single target lesion when the cumulative lesion length <=15cm. 4. Only one target lesion per patient is allowed. 5. Reference vessel diameter >=3mm and <=7mm by visual estimate 6. One or more vessel runoffs from the knee joint to the ankle
Exclusion criteria
Exclusion criteria: (General) When study patients are 1. Unwilling or unlikely to comply with the follow-up schedule 2. Given local or systematic thrombolytic therapy within 48 hours prior to the procedure 3. Allergic to heparin, aspirin, clopidogrel, ticlopidine, cilostazol, and other anticoagulants, antiplatelet therapies, contrast media, and/or paclitaxel 4. Diagnosed as having bleeding diatheses or hypercoagulable states 5. Enrolled in another device, drug, or biologic study whose follow-up period has not completed 6. Pregnant (Anatomic) 1. Ipsilateral iliac artery lesions with severe stenosis (>=70% by visual estimate) or occlusion which are not treated or have not obtained a successful residual stenosis (<30% by visual estimate) # Ipsilateral iliac artery lesions must be treated >=30 days prior to patient randomization and target lesion treatment. 2. Ispsilateral iliac artery lesions treated without drug-eluting stent and/or PEB 3. Unsuccessful treatment of any lesions in the contralateral limb # Contralateral limb lesions must be treated >=30 days prior to patient randomization and target lesion treatment. 4. A second lesion within the target femolo-popliteal artery 5. Failure to cross the true lumen of target lesion with a guidewire 6. Lesions within or adjacent to an aneurysm 7. Acute or subacute thrombus in the target vessel 8. A history of bypass surgery in the target lesion 9. A severe calcification by angiography which leads to a low expectation of successful dilation by balloon 10. Expectation of single treatment difficulty without other alternative therapies such as stent, laser, cutting balloon, and rotablator # Bail-out stenting is permitted if needed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss (difference between minimal lumen diameter post PTA and at 6-month follow-up), evaluated by quantitative angiography | — |
Secondary
| Measure | Time frame |
|---|---|
| We defined major adverse events (MAE) as deaths from all causes, clinically driven target vessel revascularization (TVR), and unplanned major amputation of the target limb. In both PEB and control groups, secondary outcomes are as follows: 1.MAE at 6-month follow-up 2.Late lumen loss at 6-month follow-up by quantitative intravascular ultrasonography 3.MAE within 24 months after PTA 4.Primary sustained clinical improvement: an improvement of Rutherford classification of one class in surviving patients without amputation and TLR at 30 days, 6, 12, and 24 months after PTA 5.Secondary sustained clinical improvement: an improvement of Rutherford classification of one class in surviving patients without amputation at 30 days, 6, 12, and 24 months after PTA, even when crinically-driven TVR was performed 6.Time to the first clinically-driven target lesion revascularization (TLR ) within 24 months after PTA 7.Technical success of PTA defined as <30% residual stenosis at the target lesion without provisional stenting 8.Technical success of intervention defined as <30% residual stenosis at the target lesion with or without provisional stenting 9.Procedural success defined as technical success of intervention without any procedural complications prior to discharge 10.Number of TLR performed within 24 months | — |
Countries
Japan
Contacts
Public ContactTsuyoshi Goto
Kurashiki Central Hospital Department of Cardiology
Outcome results
None listed