Pharmacokinetic Study of Drug-coated Angioplasty Balloons in

Status Completed

Clinical Trial 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).

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01912937
Study type	Interventional
Source	Spectranetics Corporation
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	June 2013
Completion date	July 2017

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms