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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: October 12, 2016
Last verified: October 2016
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: 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 ]
    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 ]
    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 ]

Estimated Enrollment: 25
Study Start Date: June 2013
Estimated Study Completion Date: June 2017
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   (Adult, Senior)
Sexes Eligible for Study:   All
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: October 12, 2016

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

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017