Local Paclitaxel Delivery for SFA Disease
IRRITAX
Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Single-center Pilot Study
1 other identifier
interventional
27
1 country
1
Brief Summary
To see if restenosis rates of superficial femoral artery atherosclerosis with percutaneous techniques can be improved using paclitaxel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedAugust 17, 2017
August 1, 2017
2.9 years
January 5, 2009
August 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Superficial femoral artery late lumen loss
12 months
Secondary Outcomes (1)
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
12 months
Study Arms (1)
Paclitaxel
EXPERIMENTALParticipants will receive Paclitaxel.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73126, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mazen Abu-Fadel, M.D.
Univeristy of Oklahoma
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 12, 2009
Study Start
January 1, 2009
Primary Completion
December 1, 2011
Study Completion
April 1, 2012
Last Updated
August 17, 2017
Record last verified: 2017-08