Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries

NCT00472472 | Completed Phase 1 DMC

• 1 other identifier: PACCOCATH - FEM I
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Arterial Disease

Keywords

restenosis; peripheral arterial disease; paccocath; drug-coated balloon

Outcome Measures

Primary Outcomes (1)

• angiographic late lumen loss

  6 months

Secondary Outcomes (1)

• binary restenosis rate; major adverse events

  18 months

Study Arms (2)

1

PLACEBO COMPARATOR

PTA

Device: paclitaxel coated balloon catheter (device with drug)

2

ACTIVE COMPARATOR

PTA with Paccocath

Device: paclitaxel coated balloon catheter (device with drug)

Interventions

paclitaxel coated balloon catheter (device with drug) DEVICE

PTA vs Paccocath

1; 2

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Saarland: lead

Study Sites (2)

Klinik für Strahlenheilkunde, Charité Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Institut für Diagnostische Radiologie und Neuroradiologie, Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität

Greifswald, 17487, Germany

Location

Related Publications (8)

• 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.

  PMID: 15302790 BACKGROUND

• 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.

  PMID: 15076010 BACKGROUND

• 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.

  PMID: 14563585 BACKGROUND

• 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.

  PMID: 12909076 BACKGROUND

• 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.

  PMID: 17435062 BACKGROUND

• 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.

  PMID: 17101615 BACKGROUND

• 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.

  PMID: 16864669 BACKGROUND

• 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.

  PMID: 18779447 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Jens Ricke, MD

  Klinik für Strahlenheilkunde, Charité Campus Virchow, Augustenburger Platz 1, 13353 Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Ulrich Speck, PhD

  Radiologie, Campus Mitte, Charite, 10117 Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: April 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: June 30, 2010

Record last verified: 2007-05

Locations

DE (2)