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333 results on '"Tepe, Gunnar"'

15. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study

Author

Zeller, Thomas, Torsello, Giovanni, Tepe, Gunnar, Peeters, Patrick, Scheinert, Dierk, Bosiers, Marc, Maene, Lieven, Micari, Antonio, Do, Dai-Do, Hendriks, Jeroen, Keirse, Koen, Brodmann, Marianne, Merkely, Bela, Lardenoije, Jan-Willem, Ruzsa, Zoltan, Vogel, Britta, Veroux, Pierfrancesco, Albuquerque e Castro, Joao, Periard, Daniel, Ludyga, Tomasz, Midy, Dominique, Choi, Donghoon, Lansink, Wouter, Ketelsen, Dominik, Dubenec, Steven, Banyai, Martin, Chakfe, Nabil, Roithinger, Franz Xaver, Trani, Carlo, Mansour, Hossam, Rha, Seung-Woon, Vermassen, Frank, Belenky, Alexander, Spak, Lubomir, Chalmers, Nicholas, Benko, Andrew, Kum, Steven, Won, Je Hwan, Vozar, Matej, Tan, Kong Teng, Labib, Mamdouh, de Borst, Gert-Jan, Do, Young-Soo, Teijink, Joep, Gomez, Juan Fernando, Falkowski, Aleksander, Ferreira, Luis, Matela, Jozef, Lee, Seung-Whan, Verhoeven, Bart, Mannheim, Dalit, Nessi, Franco, Vulev, Ivan, de Vries, Jean-Paul, Maly, Radovan, Kavteladze, Zaza, Turner, Douglas, Mendiz, Oscar, Kolvenbach, Ralf, Karnabatidis, Dimitrios, Cuellar, Cesar, Venermo, Maarit, Velicka, Linas, Lundberg, Goran, Frost, Martin, and Wang, Hong

Published
2018
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16. Editor's Choice – 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS)

Author

Aboyans, Victor, Ricco, Jean-Baptiste, Bartelink, Marie-Louise E.L., Björck, Martin, Brodmann, Marianne, Cohnert, Tina, Collet, Jean-Philippe, Czerny, Martin, De Carlo, Marco, Debus, Sebastian, Espinola-Klein, Christine, Kahan, Thomas, Kownator, Serge, Mazzolai, Lucia, Naylor, A. Ross, Roffi, Marco, Röther, Joachim, Sprynger, Muriel, Tendera, Michal, Tepe, Gunnar, Venermo, Maarit, Vlachopoulos, Charalambos, Desormais, Ileana, Document Reviewers, Widimsky, Petr, Kolh, Philippe, Agewall, Stefan, Bueno, Héctor, Coca, Antonio, De Borst, Gert J., Delgado, Victoria, Dick, Florian, Erol, Cetin, Ferrini, Marc, Kakkos, Stavros, Katus, Hugo A., Knuuti, Juhani, Lindholt, Jes, Mattle, Heinrich, Pieniazek, Piotr, Piepoli, Massimo Francesco, Scheinert, Dierk, Sievert, Horst, Simpson, Iain, Sulzenko, Jakub, Tamargo, Juan, Tokgozoglu, Lale, Torbicki, Adam, Tsakountakis, Nikolaos, Tuñón, José, Vega de Ceniga, Melina, Windecker, Stephan, and Zamorano, Jose Luis

Published
2018
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17. The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment

Author

Tacke, Josef, Müller-Hülsbeck, Stephan, Schröder, Henrik, Lammer, Johannes, Schürmann, Karl, Gross-Fengels, Walter, Fischbach, Roman, Textor, Jochen, Boguth, Lothar, Loewe, Christian, Häuser, Hannes, Gschwendtner, Manfred, Tepe, Gunnar, von Strandmann, Rembert Pogge, Stahnke, Stefanie, Dambach, Johannes, and Hausegger, Klaus

Published
2019
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28. Response by Schneider et al to Letter Regarding Article, “Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial”

Author

Schneider, Peter A., Laird, John R., Tepe, Gunnar, Brodmann, Marianne, Zeller, Thomas, Scheinert, Dierk, Metzger, Christopher, Micari, Antonio, Sachar, Ravish, Jaff, Michael R., Wang, Hong, Hasenbank, Melissa S., and Krishnan, Prakash

Published
2018
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33. Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval.

Author

Noory, Elias, Tepe, Gunnar, Piorkowski, Michael, Thieme, Marcus, Müller-Hülsbeck, Stefan, Brechtel, Klaus, Lichtenberg, Michael, Beschorner, Ulrich, Böhme, Tanja, and Zeller, Thomas

Subjects
PERIPHERAL vascular diseases, TRANSLUMINAL angioplasty, CATHETERS, FIREPROOFING agents, ARTERIAL diseases, STEARIC acid
Abstract

Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval. Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 μg/mm2) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE). Fifty-two subjects were enrolled, 69% men, median age 69 (49–83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (−0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively. The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective. [ABSTRACT FROM AUTHOR]

Published
2023
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35. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS)

Author

Aboyans, Victor, Ricco, Jean-Baptiste, Bartelink, Marie-Louise E.L., Bjorck, Martin, Brodmann, Marianne, Cohnert, Tina, Collet, Jean-Philippe, Czerny, Martin, De Carlo, Marco, Debusa, Sebastian, Espinola-Klein, Christine, Kahan, Thomas, Kownator, Serge, Mazzolai, Lucia, Naylora, A. Ross, Roffi, Marco, Rotherb, Joachim, Sprynger, Muriel, Tendera, Michal, Tepe, Gunnar, Venermoa, Maarit, Vlachopoulos, Charalambos, and Desormais, Ileana

Published
2018
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40. 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 (CardioVascular and Interventional Radiology, (2021), 44, 2, (207-217), 10.1007/s00270-020-02663-7)

Author

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

Abstract

The original version of this paper did not contain a list of BIOLUX P-III investigators. The purpose of this addendum is to acknowledge the contribution of all investigators who participated in the study.

Published
2021
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41. 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 (J Endovasc Ther., (2020), 27, 2, (304-315), 10.1177/1526602819898804)

Author

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

Abstract

The authors would like to acknowledge the contribution of the investigators who participated in the study by listing them as ‘collaborators’ in the article. Gunnar Tepe, MD1, Thomas Zeller, MD2, Matej Moscovic, MD3, Jean-Marc Corpataux, MD4, Johnny Kent Christensen, MD5, Koen Keirse, MD6, Giovanni Nano, MD7, Henrik Schroeder, MD8, Christoph A. Binkert, MD, MBA9, Marianne Brodmann, MD10 and BIOLUX P-III investigators 1Department of Radiology, Klinikum Rosenheim, Rosenheim, Germany 2Clinic Cardiology and Angiology II, Universitäts-Herzzentrum Freiburg–Bad Krozingen, Bad Krozingen, Germany 3Angiology Clinic, Institute of Cardiovascular Diseases, Kosice, Slovakia 4Department of Vascular Surgery, Lausanne University Hospital, Lausanne, Switzerland 5Department of Radiology, Kolding Hospital, Kolding, Denmark 6Department of Vascular Surgery, Regional Hospital Heilig Hart, Tienen, Belgium 71st Vascular Surgery Department, IRCCS Policlinico San Donato, San Donato Milanese, Italy 8Center for Diagnostic Radiology and Minimally Invasive Therapy, Jewish Hospital, Berlin, Germany 9Radiology Institute, Kantonsspital Winterthur, Winterthur, Switzerland 10Division of Angiology, Department of Internal Medicine, Medical University Graz, Austria BIOLUX P-III investigators: Marianne Brodmann, Thomas Zeller, Jean-Marc Corpataux, Matej Moscovic, Gunnar Tepe, Koen Keirse, Giovanni Nano, Johannes B. Dahm, Johnny Kent Christensen, Reza Ghotbi, Christoph Binkert, Henrik Schröder, Denis Henroteaux, John Wang Chaw Chian, Eric Rosset, Enrique Alejandre Lafont, Sabrina Houthoofd, Miguel Araujo; Shaiful Azmi Yahaya, Don Robertson, Martin Freund, Lonneke Yo, Uei Pua, Roxanne Wu, Frank Hammer, Michael Lichtenberg, Janne Korhonen, Della Schiava, Ralf Langhoff, Stefano Michelagnoli, Secundino Llagostera, Jose-Maria Romero, Max Amor, Daniel Kretzschmar, Steven Kum, Patrice Mwipatayi, Albert J Smeets, Francisco Javier Serrano Hernando, Jost Philipp Schäfer, Gil Marques, Jos C. van den Berg, Ramesh Velu, Karlis Kupcs.

Published
2021
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42. Orbital Atherectomy Prior to Drug-Coated Balloon Angioplasty in Calcified Infrapopliteal Lesions: A Randomized, Multicenter Pilot Study.

Author

Zeller, Thomas, Giannopoulos, Stefanos, Brodmann, Marianne, Werner, Martin, Andrassy, Martin, Schmidt, Andrej, Blessing, Erwin, Tepe, Gunnar, and Armstrong, Ehrin J.

Abstract

Purpose: Optimal balloon angioplasty for infrapopliteal lesions is often limited by severe calcification, which has been associated with decreased procedural success and lower long-term patency. Materials and Methods: This was a prospective, randomized, multicenter pilot trial that included adult subjects with calcified lesions located from the popliteal segment below the knee (BTK) joint to within 5 cm above the ankle with ≥70% diameter stenosis by angiography. Patients were randomized 1:1 to undergo orbital atherectomy (OA) with adjunctive drug-coated balloon (DCB) angioplasty versus plain balloon angioplasty (BA) and DCB angioplasty (control). The periprocedural and 12 month outcomes of both procedures were compared. Results: Overall, 66 subjects (OA + DCB = 32 vs control = 34) were included in an intention to treat analysis. Baseline demographics and lesion characteristics were well-balanced. The mean lesion length was 101.3 mm (SD = 72.8 mm) and 78.8 (SD = 61.0 mm) in the OA + DCB and control groups, respectively, with almost all lesions having severe calcification per the Peripheral Academic Research Consortium (PARC) criteria. Chronic total occlusions (CTOs) were present in 43.8% and 35.3% of the patients in the OA + DCB and control groups, respectively. The technical success of OA + DCB versus DCB was 81.8% and 89.2%, respectively, with 3 slow flow/no reflow, 1 perforation, 1 severe dissection occurred in OA + DCB group, and one distal embolization occurred in the control group. The target lesion primary patency rate was numerically higher in the OA + DCB versus control group at 6 (88.2% vs 50.0%, p=0.065) and 12 month follow-up (88.2% vs 54.5%, p=0.076). The 12 month freedom from major adverse events, clinically-driven target lesion revascularization, major amputation, and all-cause mortality rates were similar between both groups. Conclusion: The results of the Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified BTK (OPTIMIZE BTK) pilot study indicated that utilization of OA + DCB is safe for infrapopliteal disease. Further prospective adequately powered studies should investigate the potential benefit of combined OA + DCB for BTK lesions. [ABSTRACT FROM AUTHOR]

Published
2022
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43. Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry.

Author

Thieme, Marcus, Arjumand, Jarwed, Spanagel, Markus, Tepe, Gunnar, Blessing, Erwin, Kroeg, Bernd, Reichert, Viktor, Betge, Stefan, Wickenhöfer, Ralph, Teßarek, Jörg, Ingwersen, Maja, and Krankenberg, Hans

Abstract

Purpose: This postmarketing surveillance study aimed to assess effectiveness and safety of a peripheral self-expanding stent with high torsional strength (POLARIS stent) for the treatment of de novo superficial femoral artery (SFA) lesions in the routine clinical practice. Materials and Methods: Consecutive patients with symptomatic de novo SFA occlusive disease who underwent POLARIS stent implantation were enrolled into the prospective, multicenter, observational postmarket surveillance study. Primary outcome measure was freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Main secondary outcomes were procedural success, primary clinical improvement, and freedom from major adverse cardiovascular and limb events (MACLE) throughout 24 months. Results: A total of 199 participants (70±11 years, 70.4% men) were included in the study at 9 German sites from December 2014 to August 2018. Half of them (52.6%) were current smokers, 37.6% had diabetes, and 25.0% were obese. Most participants suffered from intermittent claudication (88.4%). Mean lesion length was 98±83 mm, 43.5% of lesions were occluded, and 27.3% were severely calcified. Freedom from 12 months cdTLR was 94.4% (95% confidence interval [CI], 90.6–98.2). At 24 months, freedom from cdTLR was 88.7% (95% CI, 83.0–94.4). Procedural success was achieved in 96.2% of participants. Primary clinical improvement occurred in 87.5% and 85.4% of participants at 12 and 24 months, respectively. Freedom from MACLE was 94.8% (95% CI, 91.4–98.1) and 93.8% (95% CI, 89.9–97.6) at 12 and 24 months, respectively. Conclusions: Treatment of SFA occlusive disease in a real-world setting using the POLARIS stent with high bidirectional torsional strength is efficacious and does not raise any safety concern in the medium term. The study is registered with ClinicalTrials.gov (Identifier: NCT02307292). [ABSTRACT FROM AUTHOR]

Published
2022
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47. Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial.

Author

Gouëffic, Yann, Torsello, Giovanni, Zeller, Thomas, Esposito, Giovanni, Vermassen, Frank, Hausegger, Klaus Armin, Tepe, Gunnar, Thieme, Marcus, Gschwandtner, Michael, Kahlberg, Andrea, Schindewolf, Marc, Sapoval, Marc, Diaz-Cartelle, Juan, Stavroulakis, Konstantinos, Apruzzi, Luca, Baccellieri, Domenico, Bea, Florian, Becquemin, Jean-Pierre, Bent, Clare, and Bertoglio, Luca

Published
2022
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49. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg

Author

Tepe, Gunnar, Zeller, Thomas, Albrecht, Thomas, Heller, Stephan, Schwarzwalder, Uwe, Beregi, Jean-Paul, Claussen, Claus D., Oldenburg, Anja, Scheller, Bruno, and Speck, Ulrich

Subjects
Transluminal angioplasty -- Health aspects, Paclitaxel -- Dosage and administration, Paclitaxel -- Health aspects
Abstract

A study to examine the efficacy of paclitaxel on restenosis after angioplasty of the leg is conducted. Results indicate that paclitaxel-coated angioplasty balloons showed significant reductions in target-lesion revascularization as compared to paclitaxel-containing contrast medium.

Published
2008

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