Drug-Eluting Balloon Catheters and the Treatment of Peripheral Arterial Occlusive Disease (NCT01007578) | Clinical Trial Compass
CompletedPhase 1
Drug-Eluting Balloon Catheters and the Treatment of Peripheral Arterial Occlusive Disease
Germany14 participantsStarted 2007-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Clinically stable patients with PAOD disease, Rutherford stage 1, 2, 3, 4, or 5.
. 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.
. Age: \>18 years.
. Guide wire may successfully advance across the lesion.
. Patient was eligible for an operative vascular intervention in case of complications.
. Informed consent was signed by patient after information of possible alternatives.
. Women of childbearing potential must had negative results in serum pregnancy test and use a reliable method of contraception.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty at baseline
Timeframe: Baseline
2
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
Timeframe: 0.5 hours post-procedure
3
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
Timeframe: 1 hour post-procedure
4
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
Timeframe: 2 hours post-procedure
5
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
Timeframe: 4 hours post-procedure
6
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
. 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).
. Acutely occurring symptoms (within the last 6 weeks) with a lysis or an operation as a therapeutic option.
. Potential loss of leg due to ischemia.
. Distal blood flow over less than one lower leg blood vessel.
. Aneurysm of intended treatment blood vessel.
. Women of child bearing potential (and up to 2 years postmenopausal) without a negative pregnancy test.
. Manifest hyperthyreosis or latent hyperthyreosis without previous blocking (sodium phosphonate).
Timeframe: 8 hours post-procedure
7
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
Timeframe: 1 week post-procedure
8
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
Timeframe: 2 weeks post-procedure
9
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
Timeframe: 3 weeks post-procedure
10
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