Atherosclerosis, Occluded Femoro-popliteal Arteries, Peripheral Arterial Disease, Stenotic Femoro-popliteal Arteries
Conditions
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
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.
Interventions
DEVICEPaclitaxel-coated balloon catheter angioplasty
Paclitaxel-coated balloon catheters for the treatment of peripheral arterial occlusive disease (POAD) of the femoro-popliteal arteries
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 1 week post-procedure |
| Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty at baseline | Baseline |
| 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 | 2 weeks post-procedure |
| 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 | 0.5 hours post-procedure |
| 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 | 1 hour post-procedure |
| 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 | 2 hours post-procedure |
| 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 | 4 hours post-procedure |
| 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 | 8 hours post-procedure |
| 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 | 3 weeks post-procedure |
| 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 | 4 weeks post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Changes in blood cell counts as measure of safety at baseline | Baseline |
| Changes in blood cell counts as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure | 0.5, 1, 2, 4, 8 and 24 hours post-procedure |
| Changes in blood cell counts as measure of safety 1, 2, 3, and 4 weeks post-procedure | 1, 2, 3, and 4 weeks post-procedure |
| Changes in serum biochemistry parameters as measure of safety at baseline | Baseline |
| Changes in serum biochemistry parameters as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure | 0.5, 1, 2, 4, 8 and 24 hours post-procedure |
| Changes in serum biochemistry parameters as measure of safety 1, 2, 3, and 4 weeks post-procedure | 1, 2, 3, and 4 weeks post-procedure |
| Number of participants with adverse events (AEs) as a measure of safety | From randomization until end of study, up to 4 months |
| Number of participants with serious adverse events (SAEs) as a measure of safety | From randomization until end of study, up to 4 months |
| Number of participants with adverse device effects (ADEs) as a measure of safety | From randomization until end of study, up to 4 months |
| 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 | From randomization until end of study, up to 4 months |
Countries
Germany
Outcome results
None listed