Paclitaxel Reduces Effects of Intimal Hyperplasia (Pac1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Patrick Kelly, Sanford Health
ClinicalTrials.gov Identifier:
NCT01454778
First received: April 4, 2011
Last updated: December 5, 2013
Last verified: December 2013
  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: Paclitaxel Reduces Effects of 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 up to 19 months [ Time Frame: up to 19 months ] [ Designated as safety issue: Yes ]
    Evidence of stenosis of lower extremity 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel Drug: Paclitaxel

Paclitaxel coating 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. Once the subject is enrolled they will be monitored for a period of 19 months. 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
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

No publications provided

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
Last Updated: December 5, 2013
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
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Pathologic Processes
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014