Clinical trial NCT01007578: Drug-Eluting Balloon Catheters and the Treatment of Peripheral Arterial Occlusive Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Arterial Disease
Stenotic Femoro-popliteal Arteries
Occluded Femoro-popliteal Arteries
Atherosclerosis
Keywords: 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
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-11-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty at baseline
timeFrame: Baseline
measure: 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
timeFrame: 0.5 hours post-procedure
measure: 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
timeFrame: 1 hour post-procedure
measure: 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
timeFrame: 2 hours post-procedure
measure: 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
timeFrame: 4 hours post-procedure
measure: 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
timeFrame: 8 hours post-procedure
measure: 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
timeFrame: 1 week post-procedure
measure: 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
timeFrame: 2 weeks post-procedure
measure: 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
timeFrame: 3 weeks post-procedure
measure: 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
timeFrame: 4 weeks post-procedure
Secondary outcomes:
measure: Changes in blood cell counts as measure of safety at baseline
timeFrame: Baseline
measure: Changes in blood cell counts as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure
timeFrame: 0.5, 1, 2, 4, 8 and 24 hours post-procedure
measure: Changes in blood cell counts as measure of safety 1, 2, 3, and 4 weeks post-procedure
timeFrame: 1, 2, 3, and 4 weeks post-procedure
measure: Changes in serum biochemistry parameters as measure of safety at baseline
timeFrame: Baseline
measure: Changes in serum biochemistry parameters as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure
timeFrame: 0.5, 1, 2, 4, 8 and 24 hours post-procedure
measure: Changes in serum biochemistry parameters as measure of safety 1, 2, 3, and 4 weeks post-procedure
timeFrame: 1, 2, 3, and 4 weeks post-procedure
measure: Number of participants with adverse events (AEs) as a measure of safety
timeFrame: From randomization until end of study, up to 4 months
measure: Number of participants with serious adverse events (SAEs) as a measure of safety
timeFrame: From randomization until end of study, up to 4 months
measure: Number of participants with adverse device effects (ADEs) as a measure of safety
timeFrame: From randomization until end of study, up to 4 months
measure: 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
timeFrame: From randomization until end of study, up to 4 months
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: