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The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per IFU with the Lutonix Catheter. Subjects will have a Duplex Ultrasound and clinical follow-up through two (2) years.
The Lutonix® 035 Drug Coated Balloon PTA Catheter (Lutonix® Catheter) has been approved by the Food and Drug Administration (P130024) for percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm.The purpose of this trial is to assess the safety and effectiveness of the Lutonix Catheter for treatment of stenosis or occlusion of the femoral and popliteal arteries in the US female population. This study will enroll 160 female patients at a minimum of 10 US centers and a maximum of 25.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Femoral Artery Stenosis
Lutonix035 Drug Coated Balloon PTA Catheter
Wellmont CVA Heart Institute
Enrolling by invitation
C. R. Bard
Published on BioPortfolio: 2016-06-27T20:53:21-0400
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The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral a...
The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropr...
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