Prevention of Restenosis Following Revascularization

A Phase II Trial of ABI-007 (Paclitaxel Albumin-bound Particles) for the Prevention of Restenosis Following Revascularization of the Superficial Femoral Artery (SFA)

The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)

Inclusion Criteria:

• Male or non-pregnant and non-lactating female and greater than or equal to 18 years of age. All females if child bearing potential must have a negative serum pregnancy test
• Patient is determined to have peripheral artery disease (PAD) classified as Rutherford category 1-4 (grade I/II) - mild, moderate, or severe claudication or ischemic rest pain
• Patient has de novo lesion causing occlusion or an angiographic stenosis of at least 50% in the superficial femoral artery
• Patient has a single or multiple lesions located in the superficial femoral artery with a total length 5-15 cm.
• Normal vessel diameter of the SFA is 4-6 mm
• Patient must have a visibly patent (by angiography) popliteal artery below the target lesion
• No residual flow limiting dissection or residual stenosis greater 30% (visual estimate) after percutaneous balloon angioplasty (PTA) or provisional stenting. Treatment with provisional stenting will be allowed only for flow-limiting dissection, grade C/D or greater than 30 % residual stenosis angiographically after angioplasty alone.
• No target vessel thrombosis confirmed angiography post-PTA procedure
• No distal embolization within target limb
• Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to any premedication, prior to performance of revascularization procedures, and prior to participation in any study-related activities

Exclusion Criteria:

• Women of child bearing potential who do not use adequate contraception
• Patients who have experienced acute onset of claudication
• History of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia
• Patients with lesions requiring treatment with atherectomy or primary stenting
• Target lesion in which PTA failure would require treatment by provisional stenting with more than 2 stents
• Patient has a life expectancy of less than 36 months or there are factors making clinical follow up difficult (no fixed address, etc)
• Additional planned vascular procedure in treated extremity (note that concurrent endovascular treatment of iliac disease is allowable)
• Patient is immunosuppressed or is HIV positive
• Any individual who may refuse a blood transfusion
• Documented major gastrointestinal bleeding within 3 months
• The following lab values at baseline are exclusionary:
• Serum creatinine greater or equal to 2.5 mg/dl
• Platelet count less than 100,000 cells/mm^3
• Uncorrectable coagulopathy with international normalized ratio (INR) greater than 2.0
• Absolute Neutrophil Count (ANC) less than 2000 cells mm^3
• Hemoglobin (Hgb) less than 9 g/dl
• Total Bilirubin greater than 1.5 mg/dl
• Alanine transaminase (SGPT) greater than 2.5 x upper limit normal range (ULN)
• Aspartate transaminase (SGOT) greater than 2.5 x ULN
• Alkaline phosphatase greater than 2.5 x ULN
• Total cholesterol greater than 350 mg/dl or Low Density Lipoprotein greater than 200 mg/dl
• Known allergies/hypersensitivity/contraindication to the study drug, to taxanes, to any required study treatment:aspirin, heparin, clopidogrel bisulfate, stent materials, or to ticlopidine, or dipyridamole
• Patient treated with bivalirudin (Angiomax)
• Pre-existing sensory neuropathy of National Cancer Institute (NCI) Toxicity Grade >1
• Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational trial
• Renal failure requiring hemodialysis
• Lower extremity or pedal pulse