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

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