Lutonix Global SFA Registry

November 7, 2016 updated by: C. R. Bard

A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter

The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

691

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

  • Austria
      • Vienna, Austria, 1090
        • Allgemeines Krankenhaus Wien
  • Belgium
      • Antwerp, Belgium, 2020
        • ZNA Campus Middelheim
  • France
      • Dijon, France, 21079
        • CHU Le Bocage
  • Germany
      • Arnsberg, Germany, 59759
        • Karolinen Hospital Huesten
      • Muenchen, Germany, 80331
        • Diakoniewerk Muenchen
      • Sonneberg, Germany, 96515
        • Medinos Kliniken Sonneberg
      • Viechtach, Germany, 94234
        • Kreiskrankenhaus Viechtach
      • Weiden, Germany, 92637
        • Klinikum Weiden
  • Greece
      • Patras, Greece, 26504
        • University General Hospital of Patras
  • Italy
      • Asti, Italy, 14100
        • AO Cardinal Massaia
      • San Donato Milanese, Italy, 20097
        • IRCCS Policlinico San Donato
      • Sondalo, Italy, 23035
        • Azienda Ospedaliera della Valtellina e dalla Valchiavenna
      • Torino, Italy
        • AO Ordine Mauriziano
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im. Biziel
      • Poznan, Poland, 61-848
        • Szpital Kliniczny Przemienienia Pańskiego
      • Torun, Poland, 87-100
        • Voivodship Specialist Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinico Barcelona
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool
      • London, United Kingdom, SE1 7EH
        • St Thomas' Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital
      • Newcastle upon Tyne, United Kingdom, WE7 7DN
        • Freeman 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital patients (global registry)

Description

Inclusion Criteria:

  • Male or non-pregnant female ≥18 years of age;
  • Rutherford Clinical Category ≤ 4;
  • Patient is willing to provide 5-year informed consent and comply with the required follow up;
  • Stenotic or obstructive vascular lesions of the femoropopliteal artery;
  • Lesion(s) can be treated with available LUTONIX Drug Coated PTA Dilatation 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 investigational drug or device study;
  • Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast;
  • Pregnant or planning on becoming pregnant or men intending to father a child;
  • Rutherford Class > 4
  • Known inadequate distal outflow or planned future 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lutonix Drug Coated Balloon
Paclitaxel coated ballooncatheter
Device: Lutonix Drug Coated Balloon
Subject will receive treatment with the Lutonix Drug Coated Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from Target Lesion Revascularization (TLR)
Time Frame: 12 months
Efficacy: Freedom from TLR at 12 months.
12 months
Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death
Time Frame: 30 days
Safety: Freedom at 30 days from TVR, major index limb amputation, and device- and procedure-related death
30 days

Collaborators and Investigators

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

Sponsor

C. R. Bard

Collaborators

Bard Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2012

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (ESTIMATE)

May 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL0004-01

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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