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| Name | Class |
|---|---|
| Bard Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lutonix Drug Coated Balloon | Paclitaxel coated ballooncatheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutonix Drug Coated Balloon | Device | Subject will receive treatment with the Lutonix Drug Coated Balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Hospital patients (global registry)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus Wien | Vienna | 1090 | Austria | |||
| ZNA Campus Middelheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28780030 | Derived | 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. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| 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 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |