Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries - Full Text View

Sponsored by:	University Hospital, Saarland
Information provided by:	University Hospital, Saarland
ClinicalTrials.gov Identifier:	NCT00472472

Purpose

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.

Condition	Intervention	Phase
Peripheral Arterial Disease	Device: paclitaxel coated balloon catheter (device with drug)	Phase I Phase II

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries (PACCOCATH – FEM I)

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:

angiographic late lumen loss [ Time Frame: 6 months ]

Secondary Outcome Measures:

binary restenosis rate; major adverse events [ Time Frame: 18 months ]

Enrollment:	87
Study Start Date:	April 2004
Estimated Study Completion Date:	June 2007

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

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472472

Locations

Germany
Klinik für Strahlenheilkunde, Charité Campus Virchow Klinikum
Berlin, Germany, 13353
Institut für Diagnostische Radiologie und Neuroradiologie, Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität
Greifswald, Germany, 17487

Sponsors and Collaborators

University Hospital, Saarland

Investigators

Principal Investigator:	Jens Ricke, MD	Klinik für Strahlenheilkunde, Charité Campus Virchow, Augustenburger Platz 1, 13353 Berlin, Germany
Study Director:	Ulrich Speck, PhD	Radiologie, Campus Mitte, Charite, 10117 Berlin, Germany

More Information

Publications:

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. Epub 2004 Aug 9.

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.

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.

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.

Scheller B, Speck U, Bohm M. Prevention of restenosis: is angioplasty the answer? Heart. 2007 May;93(5):539-41.

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. Epub 2006 Nov 13.

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.

Publications indexed to this study:

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. Epub 2008 Sep 8.

Study ID Numbers:	PACCOCATH – FEM I
Study First Received:	May 10, 2007
Last Updated:	May 10, 2007
ClinicalTrials.gov Identifier:	NCT00472472
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:

restenosis
peripheral arterial disease
paccocath
drug-coated balloon

Study placed in the following topic categories:

Peripheral Vascular Diseases
Paclitaxel
Vascular Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators

Cardiovascular Diseases
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009