The COPPER-A Trial: The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Above and Below the Knee
The purpose of this study is to assess the safety and efficacy of paclitaxel administration using the occlusion perfusion catheter (OPC) for the prevention of restenosis in infrainguinal de novo, restenotic femoropopliteal and infrapopliteal stenoses and occlusions, and in-stent restenosis.
• Willing and able to provide informed consent and comply with all study requirements;
• Candidate for peripheral vascular femoropopliteal or infrapopliteal percutaneous intervention;
• Must be ≥ 18 years of age;
• Rutherford category 2, 3, 4, or 5;
• Willing and able to tolerate dual anti-platelet therapy (DAPT) for a minimum of one (1) month;
• Lab work within acceptable limits according to standard of care;
• INR < 2.0 if on warfarin or not on warfarin;
• Minimum sheath size used for the interventional procedure
• 7x8 OPC Catheter - 7FR.
• 3x15 OPC, 3x15 PRESSANA(TM), or 3x8 PRESSANA(TM) - 6FR.