STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions

Exclusion Criteria

• •1. Life expectancy less than 2 years.
• •2. Suspected or detected malignancy without completed treatment (not considered cured).
• •3. Planned surgical or interventional procedures within 30 days after the study procedure.
• •4. Known impaired renal function with GFR ≤30 mL/min per 1.73 m2 and/or elevated serum creatinine \> 2.5mg/dL or on dialysis.
• •5. Active inflammatory process at the site of the planned puncture.
• •6. Acute lower limb ischemia.
• •7. Non-atherosclerotic lesion (e.g. vasculitis, dysplasia).
• •8. Necessary concurrent non-target lesion interventions involving a re-entry device, atherectomy, laser, or ablation procedures, the use of a drug eluting stent, or treatment with any other drug coated balloon.
• •9. Massive calcifications of the treated lesion (defined as angiographic evidence of dense calcification present on both sides of the vessel wall on two orthogonal views and that extends \>50 continuous mm in length; reflective 3 or 4 on the PACSS scale https://doi.org/10.1002%2Fccd.25387).
• •10. Angiographically confirmed presence of a thrombus in the target lesion.
• •11. The target lesion requiring primary stenting.
• •12. Presence of perforation, dissection (Type D or worse) or other injury in target vessel at time of enrollment.
• •13. Previous bypass graft or stent at target vessel (must be greater than 20mm from target lesion), or iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath Note: In-stent restenosis is not allowed.
• •14. Gastrointestinal or any other major bleeding in the past three months.
• •15. Known bleeding disorder or uncontrolled hypercoagulable disorder.
• •16. Myocardial infarction or any stroke within 30 days prior to the procedure.
• •17. Known intolerance to required medications (especially antiplatelets and heparin), contrast media (that cannot be adequately pre-medicated), nitinol or paclitaxel.
• •18. Pregnant and childbearing age women not using effective contraception.
• •19. Participation in another investigational study (before completing primary endpoint analysis) or previous enrollment to this study.