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Local Paclitaxel Delivery for SFA Disease (IRRITAX)

Primary Purpose

Atherosclerosis, Angioplasty, Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring atherosclerosis, angioplasty, peripheral arterial disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All subjects between 18 and 80 years of age with symptomatic claudication (Rutherford category 1-6) with TASC II type A, B, or C lesions will be invited to participate (23, 24).
  • Patients must be on appropriate pharmacologic therapy for PAD including antiplatelet agents and lipid-lowering therapy.

Exclusion Criteria:

  • Life expectancy <1year
  • Acute limb ischemia
  • Anatomy not amenable to percutaneous revascularization
  • Inability to provide informed consent
  • Renal insufficiency (creatinine clearance <40mL/min calculated using Cockcroft-Gault equation)
  • Prisoners
  • Pregnant or lactating women

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel

Arm Description

Participants will receive Paclitaxel.

Outcomes

Primary Outcome Measures

Superficial femoral artery late lumen loss

Secondary Outcome Measures

procedural success, amputation, target segment revascularization (TSR), target vessel revascularization (TVR), surgical revascularization, clinical restenosis defined by increase in Rutherford claudication grade of 1 or more

Full Information

First Posted
January 5, 2009
Last Updated
August 14, 2017
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT00821028
Brief Title
Local Paclitaxel Delivery for SFA Disease
Acronym
IRRITAX
Official Title
Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Single-center Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To see if restenosis rates of superficial femoral artery atherosclerosis with percutaneous techniques can be improved using paclitaxel.
Detailed Description
Treatment of superficial femoral artery atherosclerosis with percutaneous techniques is hindered by high restenosis rates. Paclitaxel inhibits restenosis in coronary arteries, and a few studies suggest it may be effective in reducing restenosis rates in peripheral arteries. The investigators hypothesize that delivering paclitaxel through an irrigating catheter will be superior in preventing restenosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Angioplasty, Peripheral Arterial Disease
Keywords
atherosclerosis, angioplasty, peripheral arterial disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel
Arm Type
Experimental
Arm Description
Participants will receive Paclitaxel.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel will be administered intra-arterially through an irrigating catheter to treat a diseased segment of superficial femoral artery. Dosing will be based on ther 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
Primary Outcome Measure Information:
Title
Superficial femoral artery late lumen loss
Time Frame
12 months
Secondary Outcome Measure Information:
Title
procedural success, amputation, target segment revascularization (TSR), target vessel revascularization (TVR), surgical revascularization, clinical restenosis defined by increase in Rutherford claudication grade of 1 or more
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects between 18 and 80 years of age with symptomatic claudication (Rutherford category 1-6) with TASC II type A, B, or C lesions will be invited to participate (23, 24). Patients must be on appropriate pharmacologic therapy for PAD including antiplatelet agents and lipid-lowering therapy. Exclusion Criteria: Life expectancy <1year Acute limb ischemia Anatomy not amenable to percutaneous revascularization Inability to provide informed consent Renal insufficiency (creatinine clearance <40mL/min calculated using Cockcroft-Gault equation) Prisoners Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mazen Abu-Fadel, M.D.
Organizational Affiliation
Univeristy of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73126
Country
United States

12. IPD Sharing Statement

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Local Paclitaxel Delivery for SFA Disease

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