Effects of Paclitaxel on Intimal Hyperplasia (Pac1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Kelly, Sanford Health
ClinicalTrials.gov Identifier:
NCT01454778
First received: April 4, 2011
Last updated: April 15, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Peripheral Vascular Disease
Drug: Paclitaxel

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Paclitaxel on Intimal Hyperplasia Status Post Lower Extremity Revascularization

Resource links provided by NLM:


Further study details as provided by Sanford Health:

Primary Outcome Measures:
  • Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Freedom From Amputation Event [ Time Frame: up to 10 months ] [ Designated as safety issue: Yes ]
  • Freedom From Target Vessel Revascularization Event [ Time Frame: up to 10 months ] [ Designated as safety issue: Yes ]
  • Freedom From Binary Restenosis [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
  • Number of Serious Adverse Events [ Time Frame: Up to 19 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: April 2011
Study Completion Date: April 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Taxol, Onxol

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

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454778

Locations
United States, South Dakota
Sanford Vascular Associates
Sioux Falls, South Dakota, United States, 57117
Sponsors and Collaborators
Patrick Kelly
Investigators
Principal Investigator: Patrick Kelly, MD Sanford Vascular Associates
  More Information

Responsible Party: Patrick Kelly, Principal Investigator, Sanford Health
ClinicalTrials.gov Identifier: NCT01454778     History of Changes
Other Study ID Numbers: Pac 1 
Study First Received: April 4, 2011
Results First Received: August 12, 2015
Last Updated: April 15, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Sanford Health:
restenosis
peripheral vascular disease
lower extremity ischemia
claudication

Additional relevant MeSH terms:
Hyperplasia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2016