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Drug Coated Balloon

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

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 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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lutonix® 035 Drug Coated Balloon PTA CatheterExperimental Treatment1 Intervention
This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

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Who is running the clinical trial?

C. R. BardLead Sponsor
103 Previous Clinical Trials
39,596 Total Patients Enrolled
1 Trials studying Popliteal Artery Stenosis
532 Patients Enrolled for Popliteal Artery Stenosis
Christopher Metzger, MDPrincipal InvestigatorWellmont CVA Heart Institute
3 Previous Clinical Trials
21,141 Total Patients Enrolled
~1 spots leftby Oct 2025
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