Lutonix Global SFA Registry
A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter
1 other identifier
observational
691
10 countries
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Typical duration for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedNovember 8, 2016
November 1, 2016
2.6 years
May 21, 2013
November 7, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Freedom from Target Lesion Revascularization (TLR)
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
Safety: Freedom at 30 days from TVR, major index limb amputation, and device- and procedure-related death
30 days
Study Arms (1)
Lutonix Drug Coated Balloon
Paclitaxel coated ballooncatheter
Interventions
Subject will receive treatment with the Lutonix Drug Coated Balloon
Eligibility Criteria
Hospital patients (global registry)
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
- Bard Ltdcollaborator
Study Sites (23)
Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
ZNA Campus Middelheim
Antwerp, 2020, Belgium
CHU Le Bocage
Dijon, 21079, France
Karolinen Hospital Huesten
Arnsberg, 59759, Germany
Diakoniewerk Muenchen
München, 80331, Germany
Medinos Kliniken Sonneberg
Sonneberg, 96515, Germany
Kreiskrankenhaus Viechtach
Viechtach, 94234, Germany
Klinikum Weiden
Weiden, 92637, Germany
University General Hospital of Patras
Pátrai, 26504, Greece
AO Cardinal Massaia
Asti, 14100, Italy
IRCCS Policlinico San Donato
San Donato Milanese, 20097, Italy
Azienda Ospedaliera della Valtellina e dalla Valchiavenna
Sondalo, 23035, Italy
AO Ordine Mauriziano
Torino, Italy
Szpital Uniwersytecki nr 2 im. Biziel
Bydgoszcz, 85-168, Poland
Szpital Kliniczny Przemienienia Panskiego
Poznan, 61-848, Poland
Voivodship Specialist Hospital
Torun, 87-100, Poland
Hospital Clinico Barcelona
Barcelona, 08036, Spain
Kantonsspital Aarau
Aarau, 5001, Switzerland
Royal Liverpool
Liverpool, L7 8XP, United Kingdom
St Thomas' Hospital
London, SE1 7EH, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
Freeman Hospital
Newcastle upon Tyne, WE7 7DN, United Kingdom
Related Publications (1)
Thieme M, Von Bilderling P, Paetzel C, Karnabatidis D, Perez Delgado J, Lichtenberg M; Lutonix Global SFA Registry Investigators. The 24-Month Results of the Lutonix Global SFA Registry: Worldwide Experience With Lutonix Drug-Coated Balloon. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1682-1690. doi: 10.1016/j.jcin.2017.04.041. Epub 2017 Aug 2.
PMID: 28780030DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2013
First Posted
May 29, 2013
Study Start
December 1, 2012
Primary Completion
July 1, 2015
Study Completion
September 1, 2016
Last Updated
November 8, 2016
Record last verified: 2016-11