Clinical trial NCT01864278: Lutonix Global SFA Registry
Official title: A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: Bard Ltd
First posted: 2013-05-29
Enrollment: 691
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patients (global registry)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from Target Lesion Revascularization (TLR)
timeFrame: 12 months
measure: Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Antwerp
country: Belgium
facility: ZNA Campus Middelheim
city: Dijon
country: France
facility: CHU Le Bocage
city: Arnsberg
country: Germany
facility: Karolinen Hospital Huesten
city: Muenchen
country: Germany
facility: Diakoniewerk Muenchen
city: Sonneberg
country: Germany
facility: Medinos Kliniken Sonneberg
city: Viechtach
country: Germany
facility: Kreiskrankenhaus Viechtach
city: Weiden
country: Germany
facility: Klinikum Weiden
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Asti
country: Italy
facility: AO Cardinal Massaia
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: Sondalo
country: Italy
facility: Azienda Ospedaliera della Valtellina e dalla Valchiavenna
city: Torino
country: Italy
facility: AO Ordine Mauriziano
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. Biziel
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego
city: Torun
country: Poland
facility: Voivodship Specialist Hospital
city: Barcelona
country: Spain
facility: Hospital Clinico Barcelona
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Liverpool
country: United Kingdom
facility: Royal Liverpool
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
References:
citation: 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.