Peripheral Artery Disease Clinical Trial
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
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.
Status | Completed |
Enrollment | 691 |
Est. completion date | September 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Austria | Allgemeines Krankenhaus Wien | Vienna | |
Belgium | ZNA Campus Middelheim | Antwerp | |
France | CHU Le Bocage | Dijon | |
Germany | Karolinen Hospital Huesten | Arnsberg | |
Germany | Diakoniewerk Muenchen | Muenchen | |
Germany | Medinos Kliniken Sonneberg | Sonneberg | |
Germany | Kreiskrankenhaus Viechtach | Viechtach | |
Germany | Klinikum Weiden | Weiden | |
Greece | University General Hospital of Patras | Patras | |
Italy | 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 | |
Poland | Szpital Uniwersytecki nr 2 im. Biziel | Bydgoszcz | |
Poland | Szpital Kliniczny Przemienienia Panskiego | Poznan | |
Poland | Voivodship Specialist Hospital | Torun | |
Spain | Hospital Clinico Barcelona | Barcelona | |
Switzerland | Kantonsspital Aarau | Aarau | |
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
C. R. Bard | Bard Ltd |
Austria, Belgium, France, Germany, Greece, Italy, Poland, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from Target Lesion Revascularization (TLR) | Efficacy: Freedom from TLR at 12 months. | 12 months | Yes |
Primary | 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 | Yes |
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