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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Spectranetics Corporation Identifier:
First received: July 10, 2013
Last updated: June 4, 2015
Last verified: June 2015
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: Angioplasty 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, 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

Resource links provided by NLM:

Further study details as provided by Spectranetics Corporation:

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: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCB Arm
Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)
Device: 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)

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 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).

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.
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Please refer to this study by its identifier: NCT01912937

New Zealand
Auckland City Hospital
Auckland, New Zealand
Clinical Trials New Zealand
Hamilton, New Zealand
Sponsors and Collaborators
Spectranetics Corporation
Principal Investigator: Andrew Holden, MD Auckland City Hospital
  More Information

Responsible Party: Spectranetics Corporation Identifier: NCT01912937     History of Changes
Other Study ID Numbers: TP-1363 
Study First Received: July 10, 2013
Last Updated: June 4, 2015
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by Spectranetics Corporation:
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
Tubulin Modulators processed this record on May 24, 2016