This trial is active, not recruiting.

Condition peripheral vascular disease
Treatment paclitaxel
Sponsor Patrick Kelly
Start date April 2011
End date March 2015
Trial size 50 participants
Trial identifier NCT01454778, Pac 1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
paclitaxel Taxol, Onxol
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* not to exceed 10mg total dose

Primary Outcomes

Evidence of stenosis lower extremity post revascularization up to 19 months
time frame: up to 19 months

Secondary Outcomes

Safety (adverse events frequency, severity)
time frame: Up to 19 months
Time to Amputation event
time frame: up to 19 months
Time to revascularization event
time frame: up to 19 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - ability to provide informed consent - age 18-90 years old - Rutherford 1-6 - occlusion or stenosis in the infrainguinal vessels Exclusion Criteria: - inability to pass the guide wire across the lesion - pregnant or lactating women - specific limb has not been previously treated with endovascular intervention

Additional Information

Official title Paclitaxel Reduces Effects of Intimal Hyperplasia Status Post Lower Extremity Revascularization
Principal investigator Patrick Kelly, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Sanford Health.