A Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon. (BIOPACT-RCT)

This is an interventional treatment trial for Peripheral Arterial Disease Read More

Inclusion Criteria:

• Subject is ≥18 years
• Subject has Rutherford classification 2, 3 or 4
• Subject has provided written informed consent and is willing to comply with study follow- up requirements
• De novo stenotic or occlusive lesion(s) or non-stented restenotic or occlusive lesion(s) occurring >90 days after prior plain old balloon (POBA) angioplasty or >180 days after prior DCB treatment
• Target lesion is located between the ostium of the SFA and the end of the P1 segment of the popliteal artery
• Target vessel diameter ≥4mm and ≤7mm
• Target lesion must be stenotic lesion ≤180mm in length (one long lesion or tandem lesions) by investigator's visual estimate or a total occlusion ≤120mm in length by investigator's visual estimate.

Note: tandem lesions must have a total length of ≤180mm by visual estimate and be separated by ≤30mm

• Target lesion must have angiographic evidence of ≥70% stenosis by investigator's visual estimation
• Successful, uncomplicated crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation and is judged by visual inspection to be within the true lumen. Subintimal dissection techniques may be used if re-entry occurs above the knee (ATK) and without the use of re-entry devices
• Target lesion is located at least 30mm from any stent, if target vessel was previously stented
• After pre-dilatation, the target lesion is ≤50% residual stenosis, absence of a flow-limiting dissection and treatable with available device matrix
• A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography
• At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography

Exclusion Criteria:

• Acute limb ischemia
• Patient underwent an intervention involving the target vessel within the previous 90 days
• Patient underwent any lower extremity percutaneous treatment in the ipsilateral limb using a paclitaxel-eluting stent or DCB within the previous 90 days
• Patient underwent a percutaneous transluminal angioplasty (PTA) of the target lesion using a DCB within the previous 180 days
• Women who are pregnant, breast-feeding or intend to become pregnant
• Patient has life expectancy of less than 1 year
• Patient has a known allergy to contrast medium that cannot be adequately pre-medicated
• Patient is allergic to all antiplatelet treatments
• Patient is receiving immunosuppressant therapy
• Patient has platelet count <100.000/mm3 or >700.000/mm3
• Patient has history of gastrointestinal haemorrhage requiring a transfusion within 3 months prior to the study procedure
• Patient is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT)
• Patient has history of stroke within the past 90 days
• Patient has history of myocardial infarction within the past 30 days
• Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study, or patient is planning to participate in such study prior to the completion of this study
• Patient has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure
• An intervention in the contralateral limb, planned within 30 days post-index procedure
• Patient had previous bypass surgery of the target lesion
• Patient had previous treatment of the target vessel with thrombolysis or surgery
• Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol
• Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5mm)
• Target lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy or re-entry devices
• Significant target vessel tortuosity or other parameters prohibiting access to the target lesion
• Presence of thrombus in the target vessel
• Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications
• Presence of an aortic, iliac or femoral artificial graft