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

April 4, 2011
April 15, 2016
April 2011
October 2014   (final data collection date for primary outcome measure)
  • 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

Evidence of stenosis lower extremity post revascularization up to 19 months [ Time Frame: up to 19 months ] [ Designated as safety issue: Yes ]
Evidence of stenosis of lower extremty as measured by ABI, Duplex, and Rutherford Classification post revascularization. ABI, Duplex, and Rutherford Classification will be done at 1, 4, 10, and 19 months post revascularization
Complete list of historical versions of study NCT01454778 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety (adverse events frequency, severity) [ Time Frame: Up to 19 months ] [ Designated as safety issue: Yes ]
  • Time to Amputation event [ Time Frame: up to 19 months ] [ Designated as safety issue: Yes ]
  • Time to revascularization event [ Time Frame: up to 19 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effects of Paclitaxel on Intimal Hyperplasia
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.
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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Peripheral Vascular Disease
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
Experimental: Paclitaxel
Intervention: Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01454778
Pac 1
Yes
Not Provided
Not Provided
Patrick Kelly, Sanford Health
Patrick Kelly
Not Provided
Principal Investigator: Patrick Kelly, MD Sanford Vascular Associates
Sanford Health
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP