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Drug-coated Angioplasty Balloons for Subjects With Constriction or Blockage in the Leg Arteries, Specifically the Superficial Femoral or Popliteal Arteries: A Pharmacokinetic Study (PK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01912937
First received: July 10, 2013
Last updated: July 29, 2013
Last verified: July 2013

July 10, 2013
July 29, 2013
June 2013
January 2015   (final data collection date for primary outcome measure)
  • Paclitaxel Levels [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Measurement of paclitaxel concentration in the circulating blood immediately after last balloon deployment, 1, 4, 24 hours, 7, 14, 30, 60 days and 6 months (if applicable) post-procedure.
  • Freedom from Events as a Safety Measure (Composite) [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    Freedom from device and procedure-related death through 30 days post-procedure; and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.
Same as current
Complete list of historical versions of study NCT01912937 on ClinicalTrials.gov Archive Site
Measurements of Pharmacokinetics variables: Cmax, Tmax, AUC [ Time Frame: (0-t) and half-life ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Drug-coated Angioplasty Balloons for Subjects With Constriction or Blockage in the Leg Arteries, Specifically the Superficial Femoral or Popliteal Arteries: A Pharmacokinetic Study
Prospective, Non-Randomized, Single-Arm, Multi-Center, Pharmacokinetic Study for the Treatment of Subjects Presenting With De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using a Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

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).

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Artery Disease
Device: Treatment with the CVI Drug-coated Balloon (DCB)
Treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)
Experimental: DCB Arm
Treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)
Intervention: Device: Treatment with the CVI Drug-coated Balloon (DCB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
January 2016
January 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
New Zealand
 
NCT01912937
TP-1363
Not Provided
Covidien
Covidien
Not Provided
Not Provided
Covidien
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP