Clinical trial NCT00472472: Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries
Official title: Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries (PACCOCATH - FEM I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Arterial Disease
Keywords: restenosis
peripheral arterial disease
paccocath
drug-coated balloon
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.

Detailed description: Background: Treatment of patients with peripheral arterial disease (PAD) in the femoropopliteal arteries by percutaneous intervention is still limited by high rates of restenosis. The aim of the present study is to evaluate the efficacy and safety of a novel method of short time local drug delivery based on a paclitaxel-coated balloon in femoropopliteal arteries.

Methods and results: The double-blind and randomized study enrolled n=79 patients with occlusion or stenosis of femoropopliteal arteries. Inclusion criteria were clinical Rutherford stage 1-5, occlusion or hemodynamic relevant stenosis (≥ 70 % diameter) of femoropopliteal arteries and successful guiding wire recanalization. The primary endpoint was the late lumen loss after 6 months follow-up as seen in angiography. Secondary endpoints included the rate of restenosis (a binary variable), change of ankle brachial index (ABI), rutherford class and major adverse events.

Eligibility criteria: Inclusion Criteria:

* Rutherford stage 1, 2, 3, 4 oder 5
* Occlusion or Stenosis of Superficial femoral and/or popliteal artery
* Successful guide wire passage of the lesion
* Patient suitable of vascular surgery in case of complication
* Written consent
* Patient is willing to take part in follow up examinations within the study

Exclusion Criteria:

* Acute ischemia
* Distal run off less than one vessel
* Pregnancy
* Hyperthyroidism
* Thrombocytes \<100.000/mm3 or \>700.000/mm3, Leucocytes \<3.000/mm3
* Life expectancy less than two years
* Patients not willing to enter the study

Primary outcomes:
measure: angiographic late lumen loss
timeFrame: 6 months
Secondary outcomes:
measure: binary restenosis rate; major adverse events
timeFrame: 18 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Strahlenheilkunde, Charité Campus Virchow Klinikum
city: Greifswald
country: Germany
facility: Institut für Diagnostische Radiologie und Neuroradiologie, Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität
Study officials:
affiliation: Klinik für Strahlenheilkunde, Charité Campus Virchow, Augustenburger Platz 1, 13353 Berlin, Germany
name: Jens Ricke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiologie, Campus Mitte, Charite, 10117 Berlin, Germany
name: Ulrich Speck, PhD
role: STUDY_DIRECTOR
References:
citation: Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.
citation: Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. doi: 10.1097/01.rli.0000116125.96544.64.
citation: Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8.
citation: Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Bohm M, Stoll HP. Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J. 2003 Aug;24(15):1462-7. doi: 10.1016/s0195-668x(03)00317-8.
citation: Scheller B, Speck U, Bohm M. Prevention of restenosis: is angioplasty the answer? Heart. 2007 May;93(5):539-41. doi: 10.1136/hrt.2007.118059.
citation: Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
citation: Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. doi: 10.1148/radiol.2402051248.
citation: Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.