Lutonix® 035 Drug Coated Balloon PTA Catheter for Popliteal Artery Stenosis (CONFIRM Trial)

N/A

Waitlist Available

Led By Christopher Metzger, MD

Research Sponsored by C. R. Bard

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post index procedure

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Femoral Artery Stenosis
Popliteal Artery Stenosis
Femoral Artery Blockage
Popliteal Artery Blockage

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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