Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)

Stopped early · Not applicable

Conditions studied: Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion

In brief

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 Instructions For Use (IFU) with the Lutonix® Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two (2) years.

Key facts

Study ID

NCT02813577

Run by

C. R. Bard

People needed

4

Starts

2018-04-20

Expected to finish

2019-02-18

Last updated by the study team

2020-04-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Life expectancy of <2 years;
• Subject is currently participating in an investigational drug or device study, or previously enrolled in this study. Enrollment in another investigational drug or device study during the follow up period is not allowed;
• History of stroke within 3 months;
• History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of index procedure;
• Renal failure or chronic kidney disease with serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis;
• Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel.

Where it is running

• St. Vincent Medical Group — Indianapolis, Indiana, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• Vascular Access Solutions — Orangeburg, South Carolina, United States
• Wellmont CVA Heart Institute — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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