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 range18 Years

SexALL

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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.

Exclusion criteria

✕. Previous treatment at the same location.
✕. 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.

What they're measuring

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

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

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

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

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

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

Timeframe: 8 hours post-procedure

Trial details

NCT IDNCT01007578

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-12-15

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