Local Paclitaxel Delivery for SFA Disease - Full Text View

Sponsors and Collaborators:	University of Oklahoma Atrium Medical Corporation
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00821028

Purpose

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.

Condition	Intervention
Atherosclerosis Angioplasty Peripheral Arterial Disease	Drug: Paclitaxel

MedlinePlus related topics: Angioplasty

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Randomized, Single-Center Pilot Study

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

Superficial femoral artery late lumen loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental	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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821028

Contacts

Contact: Thomas Hennebry, M.D.

(405)271-4742

thomas-hennebry@ouhsc.edu

Locations

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73126

Sponsors and Collaborators

University of Oklahoma

Atrium Medical Corporation

Investigators

Principal Investigator:

Thomas Hennebry, M.D.

Univeristy of Oklahoma

More Information

Responsible Party:	University of Oklahoma, Dept. of Internal Medicine, Cardiology Section ( Thomas Hennebry, M.D. )
Study ID Numbers:	Atrium-001
Study First Received:	January 5, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00821028
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Oklahoma:

atherosclerosis
angioplasty
peripheral arterial disease

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Peripheral Vascular Diseases

Paclitaxel
Vascular Diseases
Arteriosclerosis

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators

Cardiovascular Diseases
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009