Effects of Paclitaxel on Intimal Hyperplasia (Pac1)

Effects of Paclitaxel on Intimal Hyperplasia Status Post Lower Extremity Revascularization

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Drug: Paclitaxel

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117
      • Sanford Vascular Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Paclitaxel

Drug: 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; Other Names: Taxol, Onxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Patrick Kelly
• Investigators: Principal Investigator: Patrick Kelly, MD, Sanford Vascular Associates

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: October 16, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Estimate): May 24, 2016
• Last Update Submitted That Met QC Criteria: April 15, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: claudication; peripheral vascular disease; restenosis; lower extremity ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Hyperplasia; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: PAC 1