Peripheral Vascular Disease
Conditions
Keywords
restenosis, peripheral vascular disease, lower extremity ischemia, claudication
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.
Interventions
DRUGPaclitaxel
Paclitaxel 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
Sponsors
Patrick Kelly
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months | 10 months | The Ankle-Brachial Index is calculated as a ratio of the ankle blood pressure and the arm blood pressure. The ABI and Rutherford Classification will be assessed at 10 months post revascularization |
| Rutherford Classification of Peripheral Arterial Disease | 10 months | Evidence of stenosis of lower extremity as measured by the Rutherford Classification post revascularization. The ABI and Rutherford Classification will be assessed at 10 months post revascularization with a lower Rutherford score indicating a better outcome. 0 = Asymptomatic, 1 = Mild Claudication, 2 = Moderate Claudication, 3 = Severe Claudication, 4 = Ischemic Rest Pain, 5 = Minor Tissue Loss, 6 = Ulceration or Gangrene |
Secondary
| Measure | Time frame |
|---|---|
| Freedom From Amputation Event | up to 10 months |
| Freedom From Target Vessel Revascularization Event | up to 10 months |
| Freedom From Binary Restenosis | 10 months |
| Number of Serious Adverse Events | Up to 19 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel Paclitaxel: Paclitaxel 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 | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Paclitaxel |
|---|---|
| Age, Customized | 71.5 years |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 50 |
| serious Total, serious adverse events | 2 / 50 |
Outcome results
Primary
Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months
The Ankle-Brachial Index is calculated as a ratio of the ankle blood pressure and the arm blood pressure. The ABI and Rutherford Classification will be assessed at 10 months post revascularization
Time frame: 10 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paclitaxel | Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months | 0.93 ratio | Standard Deviation 0.22 |
Primary
Rutherford Classification of Peripheral Arterial Disease
Evidence of stenosis of lower extremity as measured by the Rutherford Classification post revascularization. The ABI and Rutherford Classification will be assessed at 10 months post revascularization with a lower Rutherford score indicating a better outcome. 0 = Asymptomatic, 1 = Mild Claudication, 2 = Moderate Claudication, 3 = Severe Claudication, 4 = Ischemic Rest Pain, 5 = Minor Tissue Loss, 6 = Ulceration or Gangrene
Time frame: 10 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paclitaxel | Rutherford Classification of Peripheral Arterial Disease | 0.63 units on a scale | Standard Deviation 0.95 |
Secondary
Freedom From Amputation Event
Time frame: up to 10 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel | Freedom From Amputation Event | 100 percentage of participants |
Secondary
Freedom From Binary Restenosis
Time frame: 10 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel | Freedom From Binary Restenosis | 80 percentage of participants |
Secondary
Freedom From Target Vessel Revascularization Event
Time frame: up to 10 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel | Freedom From Target Vessel Revascularization Event | 86 percentage of participants |
Secondary
Number of Serious Adverse Events
Time frame: Up to 19 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel | Number of Serious Adverse Events | 2 Number of SAE's |