Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Information provided by (Responsible Party):
Covidien Identifier:
First received: July 10, 2013
Last updated: July 29, 2013
Last verified: July 2013

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).

Condition Intervention Phase
Peripheral Artery Disease
Device: Treatment with the CVI Drug-coated Balloon (DCB)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Covidien:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Measurements of Pharmacokinetics variables: Cmax, Tmax, AUC [ Time Frame: (0-t) and half-life ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: June 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCB Arm
Treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)
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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01912937

New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand
Contact: Andrew Holden, MD    + 64 9 307 4949      
Principal Investigator: Andrew Holden, MD         
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Covidien Identifier: NCT01912937     History of Changes
Other Study ID Numbers: TP-1363
Study First Received: July 10, 2013
Last Updated: July 29, 2013
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by Covidien:
Percutaneous Transluminal Angioplasty
Balloon Catheter
Peripheral Artery Disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on February 27, 2015