The OPC 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. Subjects will be treated with the endovascular intervention selected by the treating physician in SFA reference vessels ranging from 4mm to 7mm in diameter and infrapopliteal vessels ranging from 2mm to 4mm. Following the achievement of optimal interventional results (less than thirty (30) percent residual stenosis without stenting) the OPC will be placed at the interventional treatment area and paclitaxel will be delivered to the treated segment. Data will be collected to assess acute safety, long-term safety and durability to demonstrate the safety and efficacy of paclitaxel delivered with the ACT, Inc. OPC device.

General Inclusion Criteria:

• 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.

General Exclusion Criteria:

• Life expectancy < three (3) years;
• Planned amputation prior to procedure;
• Pregnancy or nursing (a pregnancy test is required for all women of childbearing capabilities ≤ 7 days prior to the index procedure);
• Previous intervention of the target lesion with a drug eluting balloon or drug delivery catheter;
• Any treatment in the target vessel with drug eluting balloon;
• Acute limb ischemia
• Known allergy to paclitaxel;
• Known hypersensitivity to other drugs manufactured in Cremophor® EL (polyoxyethylated castor oil; e.g. Drugs containing polyoxyethylated castor oil are drugs such as miconazole, cyclosporine injection, nelfinavir mesylate, saperconazole, tacrolimus, and xenaderm ointment);
• Known allergy to anticoagulants;
• Known TRUE acetylsalicylic acid (ASA) allergy;
• Use of glycoprotein (GP) IIb/IIIa inhibitors during the procedure visit within 30 days following the index procedure;
• Target lesion treated with a cryoplasty balloon at the time of the index procedure;
• Hemorrhagic stroke within six (6) months;
• Renal failure or chronic kidney disease with GFR ≤30 mL/min or MDRD GFR ≤30 mL/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
• Prior vascular surgery of the index limb;
• Current enrollment in another investigational device or drug study;
• After obtaining informed consent, at any point up to introduction of the OPC, the investigator determines the study subject is not appropriate for the study.

Angiographic Inclusion Criteria:

• Reference vessel diameter (RVD) ≥ 4 mm and ≤ 7 mm for femoropopliteal arteries or ≥ 2 mm and ≤ 4 mm for infrapopliteal arteries;
• Either single or multiple lesions in the SFA and/or popliteal artery or single or multiple lesions in the infrapopliteal arteries (AT, PT, peroneal);
• For single lesion treatment, minimum lesion length ≥ 20 mm;
• Minimum of one patent infrapopliteal vessel;
• Pre-intervention percent DS ≥ 70%.

Angiographic Exclusion Criteria:

• Flow limiting dissection necessitating stent placement prior to OPC use;
• Post PTA residual stenosis ≥ 30% as visualized by treating physician;
• Perforation requiring a covered stent;
• For femoropopliteal target lesion or occlusion location extends distally beyond the P2 region of the popliteal artery or infrapopliteal lesion or occlusion location is at or proximal to the origin of the trifurcation vessel or below the ankle (top of the talus bone);
• Target lesion within a fractured stent;
• Target lesion within a stent and restenosed two (2) or more times;
• Significant (≥ 50% DS) inflow lesion or occlusion left untreated in the ipsilateral Iliac, SFA, or popliteal artery proximal to the target lesion;
• A lesion treated distal to the target lesion results in compromising inline flow distal to the target lesion;
• Visible thrombus in the target artery or proximal to the target artery.