Local Paclitaxel Delivery for SFA Disease (IRRITAX)

University of Oklahoma (OU)

Status: Completed

Conditions: Angioplasty; Peripheral Arterial Disease; Atherosclerosis

Treatments: Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00821028

Atrium-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Paclitaxel

Experimental group

Description:

Participants will receive Paclitaxel.

Treatment:

Drug: Paclitaxel