Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:

ProspectIve, SingLe-Arm, MuLti-Center, Pharmacokinetic Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon

To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or re-occluded/restenotic lesion(s).

This study investigates the inhibition of restenosis using the CVI Paclitaxel-coated PTA Catheter in the treatment of de-novo occluded/stenotic or re-occluded/ restenotic superficial femoral or popliteal arteries. The proposed clinical study will be a prospective, non-randomized, single arm, multi-center, pharmacokinetic study. The objective of the study is to describe the pharmacokinetics of paclitaxel in the blood delivered from the CVI Paclitaxel-coated PTA Catheter as a result of de novo occluded/restenotic or re-occluded/restenotic lesion(s).

Inclusion Criteria:

• Male or non-pregnant female greater than or equal to 18 years of age.
• Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

Exclusion Criteria:

• Pregnant or lactating females.
• Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.