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 range18 Years

SexFEMALE

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

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 range18 Years

SexFEMALE

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