Overview

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
Sponsor Spectranetics Corporation
Start date June 2013
End date June 2016
Trial size 25 participants
Trial identifier NCT01912937, TP-1363

Summary

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

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)
angioplasty treatment with the cvi drug-coated balloon (dcb)
Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)

Primary Outcomes

Measure
Paclitaxel Levels
time frame: up to 6 months
Freedom from Events as a Safety Measure (Composite)
time frame: up to 12 months

Secondary Outcomes

Measure
Measurements of Pharmacokinetics variables: Cmax, Tmax, AUC
time frame: (0-t) and half-life

Eligibility Criteria

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.

Additional Information

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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Spectranetics Corporation.