Korean Post-market Registry Assessing the Clinical Use and Safety of the Lutonix DCB in Femoropopliteal Arteries

July 16, 2020 updated by: C. R. Bard

A Prospective, Multicenter, Single Arm, Post-Market Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Femoropopliteal Arteries

The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice.

Study Overview

Status

Completed

Conditions

Detailed Description

The registry will enroll patients with claudication or critical limb ischemia due to stenotic lesions in femoropopliteal arteries. All subjects meeting protocol criteria will be treated with the LUTONIX Drug Coated Balloon Catheter for approved indications according to the current Instructions for Use (IFU) and followed clinically for 2 years.

Total enrollment will be approximately 250 subjects at up to 18 sites. Subject follow-up will occur at 1, 6, 12 and 24 months. The primary efficacy endpoint is freedom from target lesion revascularization at 12 months.

The primary safety endpoint is freedom at 30 days from the composite endpoint of target vessel revascularization and target lesion revascularization, major amputation and major reintervention of index limb, and device- and procedure-related death.

Study Type

Observational

Enrollment (Actual)

249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Busan Veterans Hospital
      • Busan, Korea, Republic of
        • Inje University Busan Park Hospital
      • Daegu, Korea, Republic of, 700-712
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of, 705-703
        • Yeungnam University Medical Center
      • Daejeon, Korea, Republic of, 301-721
        • Chungnam National University Hospital
      • Gwangju, Korea, Republic of, 501-757
        • Chonnam National University Hospital
      • Incheon, Korea, Republic of, 400-711
        • Inha University Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-799
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 137-040
        • Seoul ST. Mary's Hospital
      • Seoul, Korea, Republic of, 143-729
        • Konkuk University Hospital
      • Suwon, Korea, Republic of, 443-380
        • Ajou University Hospital
    • Gyeonggi
      • Bucheon, Gyeonggi, Korea, Republic of
        • Soonchunjyang University Hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, 431-796
        • Hallym University Sacred Heart Hospital
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 412-270
        • Myongji Hospital
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of
        • Kangbuk Samsung Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

General patient pool of participating hospitals or clinics

Description

Inclusion Criteria:

  • ≥19 years of age
  • Rutherford Clinical Category ≥4
  • Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow-up
  • Stenotic or obstructive vascular lesions in femoropopliteal artery(s)
  • Lesion(s) can be treated with available LUTONIX Drug Coated Balloon Catheter device size matrix per current IFU
  • At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter)

Exclusion Criteria:

  • Patient is currently participating in an active phase of another investigational drug or device study
  • Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast
  • Known inadequate distal outflow or planned future (within 30 days) treatment of vascular disease distal to the target lesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from Target Lesion Revascularization
Time Frame: 12 months
12 months
Freedom from Target Vessel and Target Lesion Revascularization
Time Frame: 30 days
30 days
Freedom from Major Amputation and Major Reintervention of index limb
Time Frame: 30 days
30 days
Freedom from device- and procedure-related death
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Investigators

  • Principal Investigator: Jae Kyu Kim, MD, Chonnam National University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KORL15100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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