check_circleStudy Completed
Peripheral Arterial Disease, Stenotic Femoro-popliteal Arteries, Occluded Femoro-popliteal Arteries, Atherosclerosis
Bayer Identifier:
NT-4601-900
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
BothAge
18 - N/ATrial summary
Enrollment Goal
14Trial Dates
September 2007 - December 2007Phase
Phase 1Could I Receive a placebo
NoProducts
Paclitaxel-coated balloon cathetersAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Herz-Zentrum Bad Krozingen | Bad 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 baselinedate_rangeTime Frame:Baselineenhanced_encryptionYesSafety Issue:
- 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-proceduredate_rangeTime Frame:0.5 hours post-procedureenhanced_encryptionYesSafety Issue:
- Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 1 hour post-proceduredate_rangeTime Frame:1 hour post-procedureenhanced_encryptionYesSafety Issue:
- Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 2 hours post-proceduredate_rangeTime Frame:2 hours post-procedureenhanced_encryptionYesSafety Issue:
- Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 4 hours post-proceduredate_rangeTime Frame:4 hours post-procedureenhanced_encryptionYesSafety Issue:
- Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 8 hours post-proceduredate_rangeTime Frame:8 hours post-procedureenhanced_encryptionYesSafety Issue:
- Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 1 week post-proceduredate_rangeTime Frame:1 week post-procedureenhanced_encryptionYesSafety Issue:
- Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 2 weeks post-proceduredate_rangeTime Frame:2 weeks post-procedureenhanced_encryptionYesSafety Issue:
- Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 3 weeks post-proceduredate_rangeTime Frame:3 weeks post-procedureenhanced_encryptionYesSafety Issue:
- Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 4 weeks post-proceduredate_rangeTime Frame:4 weeks post-procedureenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Changes in blood cell counts as measure of safety at baselinedate_rangeTime Frame:Baselineenhanced_encryptionYesSafety Issue:
- Changes in blood cell counts as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-proceduredate_rangeTime Frame:0.5, 1, 2, 4, 8 and 24 hours post-procedureenhanced_encryptionYesSafety Issue:
- Changes in blood cell counts as measure of safety 1, 2, 3, and 4 weeks post-proceduredate_rangeTime Frame:1, 2, 3, and 4 weeks post-procedureenhanced_encryptionYesSafety Issue:
- Changes in serum biochemistry parameters as measure of safety at baselinedate_rangeTime Frame:Baselineenhanced_encryptionYesSafety Issue:
- Changes in serum biochemistry parameters as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-proceduredate_rangeTime Frame:0.5, 1, 2, 4, 8 and 24 hours post-procedureenhanced_encryptionYesSafety Issue:
- Changes in serum biochemistry parameters as measure of safety 1, 2, 3, and 4 weeks post-proceduredate_rangeTime Frame:1, 2, 3, and 4 weeks post-procedureenhanced_encryptionYesSafety Issue:
- Number of participants with adverse events (AEs) as a measure of safetydate_rangeTime Frame:From randomization until end of study, up to 4 monthsenhanced_encryptionYesSafety Issue:
- Number of participants with serious adverse events (SAEs) as a measure of safetydate_rangeTime Frame:From randomization until end of study, up to 4 monthsenhanced_encryptionYesSafety Issue:
- Number of participants with adverse device effects (ADEs) as a measure of safetydate_rangeTime Frame:From randomization until end of study, up to 4 monthsenhanced_encryptionYesSafety Issue:
- 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 tolerabilitydate_rangeTime Frame:From randomization until end of study, up to 4 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DeviceTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1