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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01912937
First Posted: July 31, 2013
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Spectranetics Corporation
  Purpose
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: None (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 ]

Enrollment: 25
Actual Study Start Date: June 2013
Study Completion Date: July 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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912937


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

Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01912937     History of Changes
Other Study ID Numbers: TP-1363
First Submitted: July 10, 2013
First Posted: July 31, 2013
Last Update Posted: October 18, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action