Status:
COMPLETED
Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries
Lead Sponsor:
University Hospital, Saarland
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-95 years
Phase:
PHASE1
PHASE2
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...
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 prese...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00472472
Start Date
April 1 2004
End Date
July 1 2007
Last Update
June 30 2010
Active Locations (2)
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1
Klinik für Strahlenheilkunde, Charité Campus Virchow Klinikum
Berlin, Germany, 13353
2
Institut für Diagnostische Radiologie und Neuroradiologie, Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität
Greifswald, Germany, 17487