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

NCT02813577 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-04-24

Study results available
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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.

Conditions

  • Femoral Artery Stenosis
  • Popliteal Artery Stenosis
  • Femoral Artery Occlusion
  • Popliteal Artery Occlusion

Interventions

DEVICE

Lutonix® 035 Drug Coated Balloon PTA Catheter

Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Christopher Metzger, MD · Wellmont CVA Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2019-02-18
Completion
2019-02-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02813577 on ClinicalTrials.gov