Drug-Eluting Balloon Catheters and the Treatment of Peripheral Arterial Occlusive Disease

This study has been completed.
Sponsor:
Information provided by:
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT01007578
First received: November 3, 2009
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to determine plasma levels of paclitaxel and catheter tolerability subsequent to treating patients with peripheral arterial occlusive disease (PAOD) with paclitaxel-coated balloon catheters.


Condition Intervention Phase
Peripheral Arterial Disease
Stenotic Femoro-popliteal Arteries
Occluded Femoro-popliteal Arteries
Atherosclerosis
Other: Paclitaxel-coated balloon catheter angioplasty
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Labeled Multicenter Study to Investigate Plasma Levels and Catheter Tolerability Following Application of Paclitaxel Coated Balloon Catheter in Patients With Stenotic, or Occluded Femoro-Popliteal Arteries Due to Atherosclerosis

Resource links provided by NLM:


Further study details as provided by MEDRAD, Inc.:

Primary Outcome Measures:
  • To determine plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty [ Time Frame: Baseline, post-procedure; 0.5, 1, 2, 4, 8 and 24 hours; and 1, 2, 3, and 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety is to be assessed by changes in blood cell counts and serum biochemistry parameters. In addition, the incidence of adverse events (AEs), serious adverse events (SAEs) and adverse device effects (ADEs)will be evaluated. [ Time Frame: Baseline, post-procedure; 0.5, 1, 2, 4, 8 and 24 hours; and 1, 2, 3, and 4 weeks ] [ Designated as safety issue: Yes ]
  • Tolerability will be assessed by adverse events (AEs) judged as possible/probable/definitely related to the paclitaxel coating and/or device by the investigator. [ Time Frame: Baseline, post-procedure; 0.5, 1, 2, 4, 8 and 24 hours; and 1, 2, 3, and 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: September 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel treatment
Paclitaxel-coated balloon catheter angioplasty treated subjects
Other: Paclitaxel-coated balloon catheter angioplasty
Paclitaxel-coated balloon catheters for the treatment of peripheral arterial occlusive disease (POAD) of the femoro-popliteal arteries

Detailed Description:

This is an open-labeled multicenter study to investigate plasma levels and catheter tolerability following application of paclitaxel-coated balloon catheter angioplasty in patients with stenotic or occluded femoro-popliteal arteries due to atherosclerosis. Safety will be assessed by changes in blood cell (leukocytes, neutrophils and thrombocytes) counts, and changes in serum biochemistry parameters. Tolerability will be assessed by adverse event occurences related to the paclitaxel-coating and/or device by the investigator.

  Eligibility

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

Inclusion Criteria:

  • Patients must have met all of the following criteria for inclusion in the study:

    1. Clinically stable patients with PAOD disease, Rutherford stage 1, 2, 3, 4, or 5.
    2. Occlusion up to 5 cm or a ≥70% diameter stenosis of up to 32 cm length in the Arteria (A.) femoralis superficialis or A. popliteal, documented by angiography prior to intervention.
    3. Age: >18 years.
    4. Guide wire may successfully advance across the lesion.
    5. Patient was eligible for an operative vascular intervention in case of complications.
    6. Informed consent was signed by patient after information of possible alternatives.
    7. Women of childbearing potential must had negative results in serum pregnancy test and use a reliable method of contraception.

Exclusion Criteria:

  • Patients who met any of the following exclusion criteria were not included in the study:

    1. Previous treatment at the same location.
    2. Close affiliation with the investigational site; e.g., a close relative of the Investigator, dependent person (e.g., employee or student of the investigational site).
    3. Acutely occurring symptoms (within the last 6 weeks) with a lysis or an operation as a therapeutic option.
    4. Potential loss of leg due to ischemia.
    5. Distal blood flow over less than one lower leg blood vessel.
    6. Aneurysm of intended treatment blood vessel.
    7. Women of child bearing potential (and up to 2 years postmenopausal) without a negative pregnancy test.
    8. Manifest hyperthyreosis or latent hyperthyreosis without previous blocking (sodium phosphonate).
    9. Blood platelet count <100.000/mm3 or >700.000/mm3, leukocyte count <3.000/mm3.
    10. Known intolerance or contra-indication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, or stainless steel, and known intolerance to contrast agents which cannot be adequately pre-treated.
    11. Illnesses (cancer, liver diseases, myocardial insufficiency) leading to protocol deviations and a reduced life expectancy (<2 years).
    12. Renal insufficiency with serum creatinine over 2.0 mg/dL.
    13. Diabetes mellitus with additional metformin therapy.
    14. Significant gastrointestinal hemorrhage in the previous 6 months.
    15. History of hemorrhagic diathesis or coagulopathy or rejection of blood transfusions due to religious or other reasons.
    16. Patient who received any investigational device or combination product for the intended indication within the 30 days prior to entering this study.
    17. Patient who had previously participated in another study using a paclitaxel coated catheter.
    18. Non-compliant or incapable patients to participate in the study (patients unable to speak or understand German language), patients not willing to answer questions regarding the study via telephone, patients rejecting an electronic storage of their patient information, or imprisoned patients.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01007578

Locations
Germany
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany
Sponsors and Collaborators
MEDRAD, Inc.
Investigators
Principal Investigator: Thomas Zeller, MD Herz-Zentrum Bad Krozingen, 79189 Bad Krozingen, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Karen M. Fraser / Director, Clinical Affairs Combination Devices, MEDRAD Interventional / Possis
ClinicalTrials.gov Identifier: NCT01007578     History of Changes
Other Study ID Numbers: NT-4601-900
Study First Received: November 3, 2009
Last Updated: October 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by MEDRAD, Inc.:
Paclitaxel
Paclitaxel-coated balloon catheters
Peripheral arterial occlusive disease (PAOD)
Plasma levels
Femoral artery
Popliteal artery
Peripheral arterial disease (PAD) including stenotic or occluded femoro-popliteal arteries due to atherosclerosis

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

ClinicalTrials.gov processed this record on July 20, 2014