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

• 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 ]

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.

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.

• Peripheral Arterial Disease
• Stenotic Femoro-popliteal Arteries
• Occluded Femoro-popliteal Arteries
• Atherosclerosis

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.