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Sponsored by: |
University of Oklahoma |
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Information provided by: | University of Oklahoma |
ClinicalTrials.gov Identifier: | NCT00821028 |
Treatment of superficial femoral artery atherosclerosis with percutaneous techniques is hindered by high restenosis rates. Paclitaxel inhibits restenosis in coronary arteries, and a few studies suggest it may be effective in reducing restenosis rates in peripheral arteries. The investigators hypothesize that delivering paclitaxel through an irrigating catheter will be superior in preventing restenosis.
Condition | Intervention |
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Atherosclerosis Angioplasty Peripheral Arterial Disease |
Drug: Paclitaxel |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Randomized, Single-Center Pilot Study |
Estimated Enrollment: | 50 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Experimental: Experimental |
Drug: Paclitaxel
Paclitaxel will be administered intra-arterially through an irrigating catheter to treat a diseased segment of superficial femoral artery. Dosing will be based on ther lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas Hennebry, M.D. | (405)271-4742 | thomas-hennebry@ouhsc.edu |
United States, Oklahoma | |
University of Oklahoma Health Sciences Center | |
Oklahoma City, Oklahoma, United States, 73126 |
Principal Investigator: | Thomas Hennebry, M.D. | Univeristy of Oklahoma |
Responsible Party: | University of Oklahoma, Dept. of Internal Medicine, Cardiology Section ( Thomas Hennebry, M.D. ) |
Study ID Numbers: | Atrium-001 |
Study First Received: | January 5, 2009 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00821028 History of Changes |
Health Authority: | United States: Food and Drug Administration |
atherosclerosis angioplasty peripheral arterial disease |
Arterial Occlusive Diseases Atherosclerosis Peripheral Vascular Diseases Paclitaxel Tubulin Modulators |
Vascular Diseases Antimitotic Agents Arteriosclerosis Antineoplastic Agents, Phytogenic |
Atherosclerosis Arterial Occlusive Diseases Peripheral Vascular Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Vascular Diseases Arteriosclerosis |
Antimitotic Agents Pharmacologic Actions Paclitaxel Therapeutic Uses Tubulin Modulators Cardiovascular Diseases Antineoplastic Agents, Phytogenic |