Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
691 participants
OBSERVATIONAL
2012-12-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Lutonix Drug Coated Balloon
Paclitaxel coated ballooncatheter
Lutonix Drug Coated Balloon
Subject will receive treatment with the Lutonix Drug Coated Balloon
Interventions
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Lutonix Drug Coated Balloon
Subject will receive treatment with the Lutonix Drug Coated Balloon
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bard Ltd
INDUSTRY
C. R. Bard
INDUSTRY
Responsible Party
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Locations
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Allgemeines Krankenhaus Wien
Vienna, , Austria
ZNA Campus Middelheim
Antwerp, , Belgium
CHU Le Bocage
Dijon, , France
Karolinen Hospital Huesten
Arnsberg, , Germany
Diakoniewerk Muenchen
München, , Germany
Medinos Kliniken Sonneberg
Sonneberg, , Germany
Kreiskrankenhaus Viechtach
Viechtach, , Germany
Klinikum Weiden
Weiden, , Germany
University General Hospital of Patras
Pátrai, , Greece
AO Cardinal Massaia
Asti, , Italy
IRCCS Policlinico San Donato
San Donato Milanese, , Italy
Azienda Ospedaliera della Valtellina e dalla Valchiavenna
Sondalo, , Italy
AO Ordine Mauriziano
Torino, , Italy
Szpital Uniwersytecki nr 2 im. Biziel
Bydgoszcz, , Poland
Szpital Kliniczny Przemienienia Panskiego
Poznan, , Poland
Voivodship Specialist Hospital
Torun, , Poland
Hospital Clinico Barcelona
Barcelona, , Spain
Kantonsspital Aarau
Aarau, , Switzerland
Royal Liverpool
Liverpool, , United Kingdom
St Thomas' Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
Other Identifiers
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CL0004-01
Identifier Type: -
Identifier Source: org_study_id