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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 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*
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 months |
| 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 | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Amputation Event | up to 10 months | |
| Freedom From Target Vessel Revascularization Event | up to 10 months | |
| Freedom From Binary Restenosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Kelly, MD | Sanford Vascular Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford Vascular Associates | Sioux Falls | South Dakota | 57117 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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*
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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*
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | ratio | 10 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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*
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toe embolism | Vascular disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psuedoaneurysm | Vascular disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick Kelly | Sanford Health | 605-312-7300 | Patrick.Kelly@SanfordHealth.org |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
|
| 10 months |
| Number of Serious Adverse Events | Up to 19 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Freedom From Amputation Event | Posted | Number | percentage of participants | up to 10 months |
|
|
|
| Secondary | Freedom From Target Vessel Revascularization Event | Posted | Number | percentage of participants | up to 10 months |
|
|
|
| Secondary | Freedom From Binary Restenosis | Posted | Number | percentage of participants | 10 months |
|
|
|
| Secondary | Number of Serious Adverse Events | Posted | Number | Number of SAE's | Up to 19 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 10 months |
|
|
|
| 2 |
| 50 |
| 37 |
| 50 |
| Restenosis of target lesion | Vascular disorders |
|
| DVT | Vascular disorders |
|
| Occlusion | Vascular disorders |
|
| Dissection | Vascular disorders |
|
| Re-stenosis in the treated limb | Vascular disorders |
|
| Poor wound healing | Vascular disorders |
|
| Pain | Injury, poisoning and procedural complications |
|
| Claudication | Vascular disorders |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |