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Sponsored by: |
University Hospital, Saarland |
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Information provided by: | University Hospital, Saarland |
ClinicalTrials.gov Identifier: | NCT00472472 |
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 |
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) |
Enrollment: | 87 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | June 2007 |
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.
Ages Eligible for Study: | 18 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Study ID Numbers: | PACCOCATH – FEM I |
Study First Received: | May 10, 2007 |
Last Updated: | May 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00472472 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
restenosis peripheral arterial disease paccocath drug-coated balloon |
Peripheral Vascular Diseases Paclitaxel Tubulin Modulators |
Vascular Diseases Antimitotic Agents Antineoplastic Agents, Phytogenic |
Peripheral Vascular Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Paclitaxel Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Vascular Diseases Cardiovascular Diseases Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |