Status:
COMPLETED
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:
Lead Sponsor:
Spectranetics Corporation
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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), oc...
Detailed 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 poplit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01912937
Start Date
June 1 2013
End Date
July 1 2017
Last Update
October 18 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Auckland City Hospital
Auckland, New Zealand
2
Clinical Trials New Zealand
Hamilton, New Zealand