Local Paclitaxel Delivery for SFA Disease

Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Single-center Pilot Study

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00821028

Acronym

IRRITAX

Enrollment

Registered

2009-01-12

Start date

2009-01-01

Completion date

2012-04-01

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty, Atherosclerosis, Peripheral Arterial Disease

Keywords

atherosclerosis, angioplasty, peripheral arterial disease

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.

Interventions

DRUGPaclitaxel

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Superficial femoral artery late lumen loss	12 months

Secondary

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	12 months

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMazen Abu-Fadel, M.D.

Univeristy of Oklahoma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026