TerminatedNot Applicable

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

Stopped: FDA allowed other data to be leveraged to meet the study requirements

United States4 participantsStarted 2018-04-20

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Freedom From the Following: All-cause Peri-operative Death at 30 Days, Index Limb Amputation Within 1 Year, Index Limb Re-intervention Within 1 Year, and Index-limb-Related Death Within 1 Year Post Index Procedure

Timeframe: 12 months post index procedure

Effectiveness: Number of Participants With Primary Patency of the Target Lesion at 12 Month Post Index Procedure.

Timeframe: 12 months post index procedure

Trial details

NCT IDNCT02813577

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-02-18

Results submitted2020-04-10

View on ClinicalTrials.gov More Femoral Artery Stenosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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.

What they're measuring

Timeframe: 12 months post index procedure

Effectiveness: Number of Participants With Primary Patency of the Target Lesion at 12 Month Post Index Procedure.

Timeframe: 12 months post index procedure