Clinical trial NCT01454778: Effects of Paclitaxel on Intimal Hyperplasia
Official title: Effects of Paclitaxel on Intimal Hyperplasia Status Post Lower Extremity Revascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: restenosis
peripheral vascular disease
lower extremity ischemia
claudication
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months
timeFrame: 10 months
measure: Rutherford Classification of Peripheral Arterial Disease
timeFrame: 10 months
Secondary outcomes:
measure: Freedom From Amputation Event
timeFrame: up to 10 months
measure: Freedom From Target Vessel Revascularization Event
timeFrame: up to 10 months
measure: Freedom From Binary Restenosis
timeFrame: 10 months
measure: Number of Serious Adverse Events
timeFrame: Up to 19 months
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Sanford Vascular Associates
state: South Dakota
Study officials:
affiliation: Sanford Vascular Associates
name: Patrick Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References: