Clinical evaluation of efficacy and safety of paclitaxel-eluting balloon (PEB) for peripheral artery disease patients with femolo-popliteal lesio

Not Applicable

• Conditions: Femolo-popliteal artery disease

• Registration Number: JPRN-UMIN000004031
• Lead Sponsor: Kurashiki Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified