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

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ClinicalTrials.gov Identifier: NCT01007578
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Peripheral Arterial Disease Stenotic Femoro-popliteal Arteries Occluded Femoro-popliteal Arteries Atherosclerosis Device: Paclitaxel-coated balloon catheter angioplasty Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Paclitaxel treatment
Paclitaxel-coated balloon catheter angioplasty treated subjects
Device: Paclitaxel-coated balloon catheter angioplasty
Paclitaxel-coated balloon catheters for the treatment of peripheral arterial occlusive disease (POAD) of the femoro-popliteal arteries



Primary Outcome Measures :
  1. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty at baseline [ Time Frame: Baseline ]
  2. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 0.5 hours post-procedure [ Time Frame: 0.5 hours post-procedure ]
  3. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 1 hour post-procedure [ Time Frame: 1 hour post-procedure ]
  4. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 2 hours post-procedure [ Time Frame: 2 hours post-procedure ]
  5. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 4 hours post-procedure [ Time Frame: 4 hours post-procedure ]
  6. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 8 hours post-procedure [ Time Frame: 8 hours post-procedure ]
  7. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 1 week post-procedure [ Time Frame: 1 week post-procedure ]
  8. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 2 weeks post-procedure [ Time Frame: 2 weeks post-procedure ]
  9. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 3 weeks post-procedure [ Time Frame: 3 weeks post-procedure ]
  10. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 4 weeks post-procedure [ Time Frame: 4 weeks post-procedure ]

Secondary Outcome Measures :
  1. Changes in blood cell counts as measure of safety at baseline [ Time Frame: Baseline ]
  2. Changes in blood cell counts as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure [ Time Frame: 0.5, 1, 2, 4, 8 and 24 hours post-procedure ]
  3. Changes in blood cell counts as measure of safety 1, 2, 3, and 4 weeks post-procedure [ Time Frame: 1, 2, 3, and 4 weeks post-procedure ]
  4. Changes in serum biochemistry parameters as measure of safety at baseline [ Time Frame: Baseline ]
  5. Changes in serum biochemistry parameters as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure [ Time Frame: 0.5, 1, 2, 4, 8 and 24 hours post-procedure ]
  6. Changes in serum biochemistry parameters as measure of safety 1, 2, 3, and 4 weeks post-procedure [ Time Frame: 1, 2, 3, and 4 weeks post-procedure ]
  7. Number of participants with adverse events (AEs) as a measure of safety [ Time Frame: From randomization until end of study, up to 4 months ]
  8. Number of participants with serious adverse events (SAEs) as a measure of safety [ Time Frame: From randomization until end of study, up to 4 months ]
  9. Number of participants with adverse device effects (ADEs) as a measure of safety [ Time Frame: From randomization until end of study, up to 4 months ]
  10. Number of participants with adverse events (AEs) judged as possible/probable/definitely related to the paclitaxel coating and/or device by the investigator as a measure of tolerability [ Time Frame: From randomization until end of study, up to 4 months ]


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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:

  • 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/mm^3 or >700.000/mm^3, leukocyte count <3.000/mm^3.
    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.

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): NCT01007578


Locations
Germany
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01007578     History of Changes
Other Study ID Numbers: NT-4601-900
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Bayer:
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:
Atherosclerosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action