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Mortality Following Treatment with Paclitaxel-Coated Devices in Real World: Correlation to Total Lifetime Dosage?

Tanja Böhme, Elias Noory, Ulrich Beschorner, Börries Jacques, Karlheinz Bürgelin, Thomas Nührenberg, Franz-Josef Neumann, Thomas Zeller,

<h4>Purpose</h4>To evaluate the all-cause mortality after treatment with paclitaxel-coated devices depending on paclitaxel exposure in real-world practice.<h4>Materials and methods</h4>A retrospective analysis of mortality of patients with at least a 3-year follow-up was performed. Patients were categorized into terciles according to the paclitaxel dosage received during the index procedure and every ... Read more >>

J Vasc Interv Radiol (Journal of vascular and interventional radiology : JVIR)
[2021, :]

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Correction to: Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry.

Gunnar Tepe, Thomas Zeller, Matej Moscovic, Jean-Marc Corpataux, Johnny Kent Christensen, Koen Keirse, Giovanni Nano, Henrik Schroeder, Christoph A Binkert, Marianne Brodmann,

Cardiovasc Intervent Radiol (Cardiovascular and interventional radiology)
[2021, 44(7):1155-1156]

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Contralateral Stenosis and Echolucent Plaque Morphology are Associated with Elevated Stroke Risk in Patients Treated with Asymptomatic Carotid Artery Stenosis within a Controlled Clinical Trial (SPACE-2).

Tilman Reiff, Hans-Henning Eckstein, Ulrich Mansmann, Olav Jansen, Gustav Fraedrich, Harald Mudra, Dittmar Böckler, Michael Böhm, Hartmut Brückmann, E Sebastian Debus, Jens Fiehler, Klaus Mathias, E Bernd Ringelstein, Jürg Schmidli, Robert Stingele, Ralf Zahn, Thomas Zeller, Wolf-Dirk Niesen, Kristian Barlinn, Andreas Binder, Jörg Glahn, Peter Arthur Ringleb, ,

<h4>Background</h4>Asymptomatic carotid artery stenosis (ACS) has a low risk of stroke. To achieve an advantage over noninterventional best medical treatment (BMT), carotid endarterectomy (CEA) or carotid artery stenting (CAS) must be performed with the lowest possible risk of stroke. Therefore, an analysis of risk-elevating factors is essential. Grade of ipsilateral ... Read more >>

J Stroke Cerebrovasc Dis (Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association)
[2021, 30(9):105940]

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The prospective GermanVasc cohort study.

Artur Kotov, Frederik Peters, Eike Sebastian Debus, Thomas Zeller, Peter Heider, Konstantinos Stavroulakis, Jürgen Remig, Andreas Gussmann, Johannes Hoffmann, Oliver Friedrich, Thomas Nolte, Christian-Alexander Behrendt,

<i>Background:</i> Previous observational studies reported a wide variation and possible room for improvement in the treatment of patients suffering from symptomatic peripheral artery disease (PAD). Yet, systematic assessment of everyday clinical practice is lacking. A General Data Protection Regulation (GDPR) compliant registry was developed and used to collect comprehensive data ... Read more >>

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2021, :]

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Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC).

Tanja Böhme, Elias Noory, Ulrich Beschorner, Frederik Lerke, Andrej Schmidt, Dierk Scheinert, Wulf Ito, Thomas Zeller, Aljoscha Rastan,

<i>Background:</i> To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. <i>Patients and methods:</i> The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral ... Read more >>

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2021, 50(5):387-393]

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CORRIGENDUM to Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry.

Gunnar Tepe, Thomas Zeller, Matej Moscovic, Jean-Marc Corpataux, Johnny Kent Christensen, Koen Keirse, Giovanni Nano, Henrik Schroeder, Christoph A Binkert, Marianne Brodmann,

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2021, 28(3):489]

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Outcomes of directional atherectomy for common femoral artery disease.

Tanja Böhme, Leonardo Romano, Roland-Richard Macharzina, Elias Noory, Ulrich Beschorner, Börries Jacques, Karlheinz Bürgelin, Peter-Christian Flügel, Thomas Zeller, Aljoscha Rastan,

<h4>Background</h4>Endovascular therapy is the first-line strategy for femoropopliteal obstructive disease. However, for lesions involving the common femoral artery (CFA) surgical endarterectomy is still the gold standard.<h4>Aims</h4>The aim of this study was to evaluate the safety and efficacy of directional atherectomy (DA) for the treatment of CFA lesions.<h4>Methods</h4>A retrospective analysis of ... Read more >>

EuroIntervention (EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology)
[2021, 17(3):260-266]

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Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.

Krishna J Rocha-Singh, Ravish Sachar, Brian G DeRubertis, Claus C A Nolte-Ernsting, John G Winscott, Prakash Krishnan, Eric C Scott, Lawrence A Garcia, Jean-Luc Baeriswyl, Gary Ansel, Kenneth Rosenfield, Thomas Zeller, ,

<h4>Background</h4>Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation.<h4>Objectives</h4>Assess the safety and effectiveness of a vessel preparation strategy with ... Read more >>

Catheter Cardiovasc Interv (Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions)
[2021, 98(3):549-558]

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Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial.

Gunnar Tepe, Marianne Brodmann, Martin Werner, William Bachinsky, Andrew Holden, Thomas Zeller, Sarang Mangalmurti, Claus Nolte-Ernsting, Barry Bertolet, Dierk Scheinert, William A Gray, ,

<h4>Objectives</h4>The study sought to compare short-term outcomes in patients with femoropopliteal artery calcification receiving vessel preparation with intravascular lithotripsy (IVL) or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) for symptomatic peripheral artery disease.<h4>Background</h4>Endovascular treatment of calcified peripheral artery lesions is associated with suboptimal vessel expansion and increased complication ... Read more >>

JACC Cardiovasc Interv (JACC. Cardiovascular interventions)
[2021, 14(12):1352-1361]

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Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial.

Aljoscha Rastan, Marianne Brodmann, Tanja Böhme, Roland Macharzina, Elias Noory, Ulrich Beschorner, Peter-Christian Flügel, Karlheinz Bürgelin, Franz-Josef Neumann, Thomas Zeller,

[Figure: see text]. ... Read more >>

Circ Cardiovasc Interv (Circulation. Cardiovascular interventions)
[2021, 14(6):e010280]

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1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon.

Ravish Sachar, Yoshimitsu Soga, Mohammad M Ansari, Amane Kozuki, Louis Lopez, Marianne Brodmann, Herman Schroë, Vijay S Ramanath, Juan Diaz-Cartelle, Thomas Zeller, ,

<h4>Objectives</h4>This study sought to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) (paclitaxel dose density 2 μg/mm<sup>2</sup>) for treating superficial femoral artery or proximal popliteal artery lesions.<h4>Background</h4>Paclitaxel-coated balloon treatment prevents reinterventions, but dose and coating characteristics differ among balloons and necessitate discrete confirmation of safety and effectiveness.<h4>Methods</h4>Patients with ... Read more >>

JACC Cardiovasc Interv (JACC. Cardiovascular interventions)
[2021, 14(10):1123-1133]

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Assessment of 5-Year Mortality Outcomes for Femoropoliteal Interventions Using Drug-Eluting Devices in the REAL-PTX Study.

Tim Wittig, Thomas Zeller, Marc Bosiers, Patrick Peeters, Steffen Brucks, Yvonne Bausback, Andrej Schmidt, Dierk Scheinert, Sabine Steiner,

JACC Cardiovasc Interv (JACC. Cardiovascular interventions)
[2021, 14(10):1165-1168]

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Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis.

Bibombe Patrice Mwipatayi, Ian Patrick Barry, Marianne Brodmann, Thomas Zeller, Ramon L Varcoe, Matej Moscovic, John Wang Chaw Chian, Johnny Kent Christensen, Shaiful Azmi Yahaya, Olufemi Ayoadeleke Oshin, Gunnar Tepe, ,

<h4>Objectives</h4>This study aims to assess the use of drug-coated balloon (DCB) in a large patient population under real-world conditions and, specifically, analyse the impact of diabetes mellitus on long term outcomes following DCB utilisation.<h4>Methods</h4>BIOLUX P-III is a prospective, international, multicentre, registry that was conducted at 41 centres. The present study ... Read more >>

Ann Vasc Surg (Annals of vascular surgery)
[2021, 75:237-252]

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Modern multidisciplinary team approach is crucial in treatment for critical limb threatening ischemia.

Jos C VAN DEN Berg, Vickie R Driver, Andrew Holden, Michael R Jaff, Robert A Lookstein, Jihad A Mustapha, Richard F Neville, Thomas Zeller, Barry T Katzen, ,

The aim of this study was to provide a brief overview of the history the multidisciplinary team approach, highlighting the benefit to the patient with critical limb threatening ischemia in relation to health care economics. Furthermore, we provided a description of the requisites and key components, showing how to build ... Read more >>

J Cardiovasc Surg (Torino) (The Journal of cardiovascular surgery)
[2021, 62(2):124-129]

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Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial.

Timothy M Sullivan, Thomas Zeller, Masato Nakamura, Peter A Gaines, ,

<h4>Purpose</h4>To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease.<h4>Materials and methods</h4>The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2021, 28(2):236-245]

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Early outcomes of patients with chronic kidney disease after revascularization for critical limb ischemia.

Asimakis Gkremoutis, Theodosios Bisdas, Giovanni Torsello, Thomas Schmitz-Rixen, Nikolaos Tsilimparis, Konstantinos Stavroulakis, ,

<h4>Background</h4>The aim of this study was to report early outcomes of patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) after revascularization for critical limb-threatening ischemia (CLTI).<h4>Methods</h4>Perioperative data of patients from the CRITISCH (critical limb ischemia) Registry, who also had NDD-CKD (stages 3 and 4), were compared to their counterparts with normal ... Read more >>

J Cardiovasc Surg (Torino) (The Journal of cardiovascular surgery)
[2021, 62(2):104-110]

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Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent.

Stefan Müller-Hülsbeck, Andrew Benko, Yoshimitsu Soga, Masahiko Fujihara, Osamu Iida, Anvar Babaev, David O'Connor, Thomas Zeller, Daniel D Dulas, Juan Diaz-Cartelle, William A Gray,

<h4>Purpose</h4>To report additional endpoints, including 2-year primary patency, patient outcomes, and safety results, as well as the initial assessment of hypoechogenic halo from the IMPERIAL Randomized Controlled Trial (RCT).<h4>Materials and methods</h4>IMPERIAL RCT is a prospective, randomized (2:1), multicenter study of patients with symptomatic femoropopliteal artery lesions (length 30-140 mm, Rutherford category ... Read more >>

Cardiovasc Intervent Radiol (Cardiovascular and interventional radiology)
[2021, 44(3):368-375]

Cited: 4 times

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Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system - 12-month results from the LOCOMOTIVE EXTENDED study.

Klaus Amendt, Thomas Zeller, Robert Proczka, Ulrich Beschorner, Nicola Troisi, Matthias Waliszewski, Ralf Langhoff, Hans Krankenberg, Andreas Hansch, Tomislav Krcmar, Vinko Vidjak, Claus Nolte-Ernsting, Alexander Hansen, Martin Sigl,

<i>Background</i>: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. <i>Patient and methods</i>: The LOCOMOTIVE EXTENDED study (Multi-<u>LOC</u> for fl<u>O</u>w li<u>M</u>iting <u>O</u>utcomes after plain old balloon angioplasty and/or drug-coated balloon <u>T</u>reatment in the infrainguinal position with the object<u>IVE</u> to implant multiple ... Read more >>

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2021, 50(3):209-216]

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Evaluation of mortality following paclitaxel drug-coated balloon angioplasty of femoropopliteal lesions in patients with ulcerations and gangrene - a single center experience.

Tanja Böhme, Elias Noory, Ulrich Beschorner, Börries Jacques, Karlheinz Bürgelin, Roland Macharzina, Lisa-Marie Kuhn, Thomas Nührenberg, Franz-Josef Neumann, Thomas Zeller,

<i>Background</i>: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel coated devices. To assess the long-term mortality after paclitaxel drug-coated (DCB) and uncoated balloon angioplasty (POBA) of femoropopliteal lesions in patients with ulcerations and gangrene in real world practice. <i>Patients and ... Read more >>

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2021, 50(2):132-138]

Cited: 1 time

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Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry.

Gunnar Tepe, Thomas Zeller, Matej Moscovic, Jean-Marc Corpataux, Johnny Kent Christensen, Koen Keirse, Giovanni Nano, Henrik Schroeder, Christoph A Binkert, Marianne Brodmann,

<h4>Purpose</h4>After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions.<h4>Methods</h4>BIOLUX P-III is a global prospective single-arm study with follow-up at 6, 12 and 24 months. The primary safety endpoint was freedom from ... Read more >>

Cardiovasc Intervent Radiol (Cardiovascular and interventional radiology)
[2021, 44(2):207-217]

Cited: 2 times

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Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent.

Michael D Dake, Fabrizio Fanelli, Aaron E Lottes, Erin E O'Leary, Heidi Reichert, Xiaohui Jiang, Weiguo Fu, Osamu Iida, Kan Zen, Marc Schermerhorn, Thomas Zeller, Gary M Ansel,

<h4>Purpose</h4>Develop a prediction model to determine the impact of patient and lesion factors on freedom from target lesion revascularization (ffTLR) for patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions.<h4>Methods</h4>Patient factors, lesion characteristics, and TLR results from five global studies were utilized for model development. ... Read more >>

Cardiovasc Intervent Radiol (Cardiovascular and interventional radiology)
[2021, 44(2):196-206]

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Stent-grafts are the best way to treat complex in-stent restenosis lesions in the superficial femoral artery: 24-month results from a multicenter randomized trial.

Marc Bosiers, Koen Deloose, Joren Callaert, Jürgen Verbist, Jeroen Hendriks, Patrick Lauwers, Herman Schroë, Wouter Lansink, Dierk Scheinert, Andrej Schmidt, Thomas Zeller, Ulrich Beschorner, Elias Noory, Giovanni Torsello, Martin Austermann, Jeroen Wauters,

<h4>Background</h4>This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the GORE<sup>®</sup> VIABAHN<sup>®</sup> Endoprosthesis with PROPATEN Bioactive Surface (W. L. Gore & Associates, Flagstaff, AZ, USA) with a standard PTA treatment. ... Read more >>

J Cardiovasc Surg (Torino) (The Journal of cardiovascular surgery)
[2020, 61(5):617-625]

Cited: 1 time

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Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial.

Tanja Böhme, Elias Noory, Klaus Brechtel, Dierk Scheinert, Marc Bosiers, Ulrich Beschorner, Thomas Zeller,

<h4>Purpose</h4>To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries.<h4>Materials and methods</h4>This prospective, multicenter, single-arm trial (<i>ClinicalTrials.gov</i>; identifier NCT01263665) enrolled 71 patients (mean age ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2021, 28(2):222-228]

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Evaluation of mortality following paclitaxel drug-coated stent angioplasty of femoropopliteal lesions in real world.

Tanja Böhme, Elias Noory, Ulrich Beschorner, Börries Jacques, Karlheinz Bürgelin, Roland Macharzina, Thomas Nührenberg, Florian Cheung, Franz-Josef Neumann, Thomas Zeller,

<h4>Objectives</h4>To evaluate the long-term mortality after paclitaxel-coated drug-eluting stent (DES) angioplasty and use of uncoated devices of femoropopliteal lesions in real world practice.<h4>Background</h4>A meta-analysis of randomized controlled trials reported an increased risk of long-term mortality after femoropopliteal angioplasty with paclitaxel-coated devices.<h4>Methods</h4>Retrospective mortality analysis of claudicants Rutherford-Becker class (RBC) 1-4 who ... Read more >>

Catheter Cardiovasc Interv (Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions)
[2020, 96(6):1306-1314]

Cited: 1 time

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Real-World Experience With a Paclitaxel-Coated Balloon in Critical Limb Ischemia: 24-Month Subgroup Outcomes of BIOLUX P-III.

Marianne Brodmann, Matej Moscovic, John Chaw Chian Wang, Giovanni Nano, Johannes Dahm, Thomas Zeller, Johnny Kent Christensen, Koen Keirse, Reza Ghotbi, Jean-Marc Corpataux, Gunnar Tepe,

<h4>Objectives</h4>The aim of the BIOLUX P-III (A Prospective, International, Multi-Centre, Post-Market All-Comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III) registry was to collect real-world data on the Passeo-18 Lux paclitaxel-coated balloon.<h4>Background</h4>Critical limb ischemia (CLI) is a severe condition ... Read more >>

JACC Cardiovasc Interv (JACC. Cardiovascular interventions)
[2020, 13(19):2289-2299]

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