- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00821028
Local Paclitaxel Delivery for SFA Disease (IRRITAX)
August 14, 2017 updated by: University of Oklahoma
Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Single-center Pilot Study
To see if restenosis rates of superficial femoral artery atherosclerosis with percutaneous techniques can be improved using paclitaxel.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73126
- University of Oklahoma Health Sciences Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Paclitaxel
Participants will receive Paclitaxel.
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Superficial femoral artery late lumen loss
Time Frame: 12 months
|
12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mazen Abu-Fadel, M.D., Univeristy of Oklahoma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (ACTUAL)
December 1, 2011
Study Completion (ACTUAL)
April 1, 2012
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
January 9, 2009
First Posted (ESTIMATE)
January 12, 2009
Study Record Updates
Last Update Posted (ACTUAL)
August 17, 2017
Last Update Submitted That Met QC Criteria
August 14, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Atherosclerosis
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- Atrium-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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