Paclitaxel Reduces Effects of Intimal Hyperplasia (Pac1)
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| First Received Date ICMJE | April 4, 2011 | ||||||||
| Last Updated Date | December 12, 2012 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Evidence of stenosis lower extremity post revascularization up to 19 months [ Time Frame: up to 19 months ] [ Designated as safety issue: Yes ] Evidence of stenosis of lower extremity as measured by ABI, Duplex, and Rutherford Classification post revascularization. ABI, Duplex, and Rutherford Classification will be done at 1, 4, 10, and 19 months post revascularization |
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| Original Primary Outcome Measures ICMJE |
Evidence of stenosis lower extremity post revascularization up to 19 months [ Time Frame: up to 19 months ] [ Designated as safety issue: Yes ] Evidence of stenosis of lower extremty as measured by ABI, Duplex, and Rutherford Classification post revascularization. ABI, Duplex, and Rutherford Classification will be done at 1, 4, 10, and 19 months post revascularization |
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| Change History | Complete list of historical versions of study NCT01454778 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Paclitaxel Reduces Effects of Intimal Hyperplasia | ||||||||
| Official Title ICMJE | Paclitaxel Reduces Effects of Intimal Hyperplasia Status Post Lower Extremity Revascularization | ||||||||
| Brief Summary | This is a single, one time, limited dose infusion of Paclitaxel, that will potentially prevent recurrent stenosis secondary to intimal hyperplasia when compared to the control group at 10 months. |
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| Detailed Description | The investigators study consists of enrolling subjects that are already scheduled to have the blood vessels in their legs re-opened. The entire study is considered standard of care, except the administration of Paclitaxel. Subjects will be consented prior to any study related procedures and prior to procedure. Subjects that meet inclusion/exclusion and the infusion of Paclitaxel has been given, will then be enrolled in the study. After the plaque area has been treated with either angioplasty (inflation of a balloon compacting it against the artery wall), stent (a wire mesh tube that presses the plaque against the artery wall and opens the artery), and/or atherectomy(removal of plaque from the artery), Dr Kelly, Dr. Schultz, Dr, Laurich, or Dr. Santos will then use an infusion balloon (a balloon with an outer layer that has holes that allows a medication to be given) to administer the Paclitaxel. Every time the infusion balloon is blown up, a single dose of medication (Paclitaxel) will be applied to the target lesion. This will be repeated until all of the target lesions have been treated or a maximum dose of 10 mg of Paclitaxel has been given. All persons enrolled in this study will be treated with Paclitaxel. Once the subject is enrolled they will be monitored for a period of 19 months. Subjects are expected to attend all follow up visits. These visits would occur even if the subject were not on the trial. Ankle-brachial index (ABI) (done by measuring blood pressure at the ankle and in the arm while a person is at rest. This test indicates if leg blockages are present) and Duplexes (An ultrasound that measures blood flow rates through the vessels. This test will indicate if leg blockages are present) will be done at the follow up visits. Both of these tests and all follow up visits are considered standard of care and will be charged to the subject or subject's insurance. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Peripheral Vascular Disease | ||||||||
| Intervention ICMJE | Drug: Paclitaxel
Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the 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 Paclitaxel Dosage: Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
Other Name: Taxol, Onxol |
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| Study Arm (s) | Experimental: Paclitaxel
Intervention: Drug: Paclitaxel |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | May 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01454778 | ||||||||
| Other Study ID Numbers ICMJE | Pac 1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Patrick Kelly, Sanford Health | ||||||||
| Study Sponsor ICMJE | Patrick Kelly | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Sanford Health | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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