Local Paclitaxel Delivery for SFA Disease

Atherosclerosis Clinical Trial

— IRRITAX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821028
• Other study ID #: Atrium-001
• Status: Completed
• Phase: N/A
• First received: January 5, 2009
• Last updated: August 14, 2017
• Start date: January 2009
• Est. completion date: April 2012

Study information

• Verified date: August 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To see if restenosis rates of superficial femoral artery atherosclerosis with percutaneous techniques can be improved using paclitaxel.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Angioplasty
• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superficial femoral artery late lumen loss		12 months
Secondary	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