Status:
COMPLETED
Effects of Paclitaxel on Intimal Hyperplasia
Lead Sponsor:
Patrick Kelly
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
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.
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 adminis...
Eligibility Criteria
Inclusion
- ability to provide informed consent
- age 18-90 years old
- Rutherford 1-6
- occlusion or stenosis in the infrainguinal vessels
Exclusion
- inability to pass the guide wire across the lesion
- pregnant or lactating women
- specific limb has not been previously treated with endovascular intervention
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01454778
Start Date
April 1 2011
End Date
April 1 2015
Last Update
May 24 2016
Active Locations (1)
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1
Sanford Vascular Associates
Sioux Falls, South Dakota, United States, 57117