Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:
This trial is active, not recruiting.
|Condition||peripheral artery disease|
|Treatment||angioplasty treatment with the cvi drug-coated balloon (dcb)|
|Phase||phase 2/phase 3|
|Start date||June 2013|
|End date||June 2016|
|Trial size||25 participants|
|Trial identifier||NCT01912937, TP-1363|
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).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||pharmacokinetics study|
|Intervention model||single group assignment|
time frame: up to 6 months
Freedom from Events as a Safety Measure (Composite)
time frame: up to 12 months
Measurements of Pharmacokinetics variables: Cmax, Tmax, AUC
time frame: (0-t) and half-life
Male or female participants at least 18 years old.
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.
|Official title||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|
|Principal investigator||Andrew Holden, MD|
|Description||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).|
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