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| Tracking Information | |||||||||
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| First Received Date † | May 10, 2007 | ||||||||
| Last Updated Date | May 10, 2007 | ||||||||
| Start Date † | April 2004 | ||||||||
| Current Primary Outcome Measures † |
angiographic late lumen loss [ Time Frame: 6 months ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures † |
binary restenosis rate; major adverse events [ Time Frame: 18 months ] | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | 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) | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase I, Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition † | Peripheral Arterial Disease | ||||||||
| Intervention † | Device: paclitaxel coated balloon catheter (device with drug) | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | 87 | ||||||||
| Estimated Completion Date | June 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 95 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | Germany | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00472472 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University Hospital, Saarland | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University Hospital, Saarland | ||||||||
| Verification Date | May 2007 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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