check_circleStudy Completed

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

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

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
14
Trial Dates
September 2007 - December 2007
Phase
Phase 1
Could I Receive a placebo
No
Products
Paclitaxel-coated balloon catheters
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Herz-Zentrum Bad KrozingenBad Krozingen, Germany

Primary Outcome

  • Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty at baseline
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    0.5 hours post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    1 hour post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    2 hours post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    4 hours post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    8 hours post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    1 week post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    2 weeks post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    3 weeks post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    4 weeks post-procedure
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Changes in blood cell counts as measure of safety at baseline
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in blood cell counts as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure
    date_rangeTime Frame:
    0.5, 1, 2, 4, 8 and 24 hours post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in blood cell counts as measure of safety 1, 2, 3, and 4 weeks post-procedure
    date_rangeTime Frame:
    1, 2, 3, and 4 weeks post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in serum biochemistry parameters as measure of safety at baseline
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in serum biochemistry parameters as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure
    date_rangeTime Frame:
    0.5, 1, 2, 4, 8 and 24 hours post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in serum biochemistry parameters as measure of safety 1, 2, 3, and 4 weeks post-procedure
    date_rangeTime Frame:
    1, 2, 3, and 4 weeks post-procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse events (AEs) as a measure of safety
    date_rangeTime Frame:
    From randomization until end of study, up to 4 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with serious adverse events (SAEs) as a measure of safety
    date_rangeTime Frame:
    From randomization until end of study, up to 4 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse device effects (ADEs) as a measure of safety
    date_rangeTime Frame:
    From randomization until end of study, up to 4 months
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    From randomization until end of study, up to 4 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1