Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries

Exclusion Criteria

• •Subjects who have undergone prior vascular surgery of the femoropopliteal artery in the index limb to treat atherosclerotic disease
• •History of major amputation in the same limb as the target lesion
• •Presence of aneurysm in the target vessel
• •Acute ischemia and/or acute thrombosis in any artery of the lower limbs
• •Acute Myocardial Infarction within 30 days before the index procedure
• •Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy
• •Known hypersensitivity or contraindication to contrast dye that cannot be adequately pre-medicated
• •Known allergies against Paclitaxel or other components of the used medical devices
• •Intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would be administered during the trial
• •Platelet count \<100,000 mm3 or \>600,000 mm3
• •Concomitant renal failure with a serum creatinine \>2.0 mg/dL
• •Receiving dialysis or immunosuppressant therapy
• •Life expectancy of less than one year
• •Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.
• •Woman who is pregnant or nursing.
• •Previously planned stenting of the index lesion
• •Use of adjunctive therapies (debulking, laser, cryoplasty, re-entry devices)
• •Planned or expected procedures (cardiac, aorta, peripheral) within 30 days after the index procedure
• •Presence of outflow lesions requiring intervention within 30 days of the index procedure
• •Perforated vessel as evidenced by extravasation of contrast media
• •Heavily calcified target lesions resistant to PTA
• •Current participation in another drug or device trial that has not completed the primary endpoint, that may potentially confound the results of this trial, or that would limit the subject's compliance with the follow-up requirements
• •Current participation in any study using drug-coated/drug-eluting technologies
• •Current participation in any study using drug-coated/drug-eluting technologies
• •Target lesion with in-stent restenosis (any stent or stent-graft)