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Author Juan Diaz Cartelle

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24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent.

Osamu Iida, Masahiko Fujihara, Daizo Kawasaki, Shinsuke Mori, Hiroyoshi Yokoi, Akira Miyamoto, Kimihiko Kichikawa, Masato Nakamura, Takao Ohki, Juan Diaz-Cartelle, Stefan Müller-Hülsbeck, William A Gray, Yoshimitsu Soga,

<h4>Purpose</h4>The purpose of the study is to report 24-month efficacy and safety results for the Japanese patient cohort in a prospective randomized controlled trial (RCT) of drug-eluting stent (DES) use for peripheral artery disease.<h4>Materials and methods</h4>Patients in the global IMPERIAL RCT had femoropopliteal lesions treated with either the Eluvia DES ... Read more >>

Cardiovasc Intervent Radiol (Cardiovascular and interventional radiology)
[2021, :]

Cited: 0 times

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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]

Cited: 0 times

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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: 2 times

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Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent.

Jaafer Golzar, Yoshimitsu Soga, Anvar Babaev, Osamu Iida, Daizo Kawasaki, William Bachinsky, James Park, Jeffery T Prem, Frank Vermassen, Juan Diaz-Cartelle, Stefan Müller-Hülsbeck, William A Gray,

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy (ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2020, 27(2):296-303]

Cited: 1 time

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The REDUCE HTN: REINFORCE: Randomized, Sham-Controlled Trial of Bipolar Radiofrequency Renal Denervation for the Treatment of Hypertension.

Michael A Weber, Ajay J Kirtane, Matthew R Weir, Jai Radhakrishnan, Tony Das, Martin Berk, Farrell Mendelsohn, Alain Bouchard, German Larrain, Michael Haase, Juan Diaz-Cartelle, Martin B Leon,

OBJECTIVES:The aim of this study was to investigate bipolar radiofrequency renal denervation in patients with hypertension not receiving medications at baseline. BACKGROUND:A blood pressure-reducing effect of renal denervation has been difficult to isolate in clinical investigations. METHODS:REDUCE HTN: REINFORCE (Renal Denervation Using the Vessix Renal Denervation System for the Treatment ... Read more >>

JACC Cardiovasc Interv (JACC. Cardiovascular interventions)
[2020, 13(4):461-470]

Cited: 5 times

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Japanese Patients Treated in the IMPERIAL Randomized Trial Comparing Eluvia and Zilver PTX Stents.

Yoshimitsu Soga, Masahiko Fujihara, Osamu Iida, Daizo Kawasaki, Keisuke Hirano, Hiroyoshi Yokoi, Akira Miyamoto, Kimihiko Kichikawa, Masato Nakamura, Takao Ohki, Juan Diaz-Cartelle, William A Gray, Stefan Müller-Hülsbeck,

PURPOSE:The purpose of the study is to report 12-month efficacy and safety results from the subgroup of Japanese patients in the prospective IMPERIAL 2:1 randomized controlled trial (RCT). METHODS:The global IMPERIAL RCT was designed to compare performance of the Eluvia Drug-Eluting Vascular Stent System (Boston Scientific, Marlborough, MA, USA) with ... Read more >>

Cardiovasc Intervent Radiol (Cardiovascular and interventional radiology)
[2020, 43(2):215-222]

Cited: 0 times

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A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial.

William A Gray, Koen Keirse, Yoshimitsu Soga, Andrew Benko, Anvar Babaev, Yoshiaki Yokoi, Henrik Schroeder, Jeffery T Prem, Andrew Holden, Jeffrey Popma, Michael R Jaff, Juan Diaz-Cartelle, Stefan Müller-Hülsbeck, ,

<h4>Background</h4>The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal ... Read more >>

Lancet (Lancet (London, England))
[2018, 392(10157):1541-1551]

Cited: 22 times

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Eluvia drug-eluting vascular stent system for the treatment of symptomatic femoropopliteal lesions.

Stefan Müller-Hülsbeck, Silke Hopf-Jensen, Koen Keirse, Thomas Zeller, Herman Schroë, Juan Diaz-Cartelle, William A Gray,

Endovascular options are increasingly recognized as primary treatments for lower extremity peripheral arterial disease inadequately responsive to noninvasive therapy. Options include balloon angioplasty and stent implantation, and newer technologies incorporate drug coatings to prevent restenosis and reduce the need for reintervention. The Eluvia drug-eluting vascular stent system (Boston Scientific, MA, ... Read more >>

Future Cardiol (Future cardiology)
[2018, 14(3):207-213]

Cited: 1 time

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12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment.

Sabine Steiner, Andrea Willfort-Ehringer, Horst Sievert, Volker Geist, Michael Lichtenberg, Costantino Del Giudice, Antoine Sauguet, Juan Diaz-Cartelle, Claudia Marx, Armin Ströbel, Ingolf Schult, Dierk Scheinert, ,

<h4>Objectives</h4>The authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months.<h4>Background</h4>Drug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study.<h4>Methods</h4>The prospective, randomized RANGER SFA ... Read more >>

JACC Cardiovasc Interv (JACC. Cardiovascular interventions)
[2018, 11(10):934-941]

Cited: 10 times

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Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up.

Stefan Müller-Hülsbeck, Koen Keirse, Thomas Zeller, Herman Schroë, Juan Diaz-Cartelle,

<h4>Purpose</h4>To report the 3-year results of the MAJESTIC first-in-human study of the Eluvia Drug-Eluting Vascular Stent System for treating femoropopliteal artery lesions.<h4>Methods</h4>The prospective, single-arm, multicenter clinical trial enrolled 57 patients with symptomatic lower limb ischemia (Rutherford category 2, 3, or 4) and lesions in the superficial femoral artery or proximal ... Read more >>

Cardiovasc Intervent Radiol (Cardiovascular and interventional radiology)
[2017, 40(12):1832-1838]

Cited: 13 times

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Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment.

Yvonne Bausback, Andrea Willfort-Ehringer, Horst Sievert, Volker Geist, Michael Lichtenberg, Costantino Del Giudice, Antoine Sauguet, Juan Diaz-Cartelle, Claudia Marx, Armin Ströbel, Ingolf Schult, Dierk Scheinert, ,

<h4>Purpose</h4>To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions.<h4>Methods</h4>Between January 2014 and October 2015, the prospective, randomized RANGER SFA study ( ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2-4) and stenotic lesions in the nonstented femoropopliteal segment ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2017, 24(4):459-467]

Cited: 17 times

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Stent placement in the superficial femoral and proximal popliteal arteries with the innova self-expanding bare metal stent system.

Richard J Powell, Michael R Jaff, Herman Schroë, Andrew Benko, Juan Diaz-Cartelle, Stefan Müller-Hülsbeck,

<h4>Objectives</h4>The SuperNOVA trial was designed to evaluate performance of the Innova Vascular Self-Expanding Stent System (Boston Scientific, Marlborough, MA) for treating lesions in the femoropopliteal arteries.<h4>Methods</h4>Patients with chronic lower limb peripheral artery disease (Rutherford category 2, 3, or 4) and atherosclerotic lesions in the native superficial femoral and/or proximal popliteal ... Read more >>

Catheter Cardiovasc Interv (Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions)
[2017, 89(6):1069-1077]

Cited: 7 times

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Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease.

Stefan Müller-Hülsbeck, Koen Keirse, Thomas Zeller, Herman Schroë, Juan Diaz-Cartelle,

<h4>Purpose</h4>To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions.<h4>Methods</h4>The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69±9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2016, 23(5):701-707]

Cited: 21 times

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Carotid stenting with distal protection in high-surgical-risk patients: one-year results of the ASTI trial.

Marc Bosiers, Dierk Scheinert, Klaus Mathias, Ralf Langhoff, Harald Mudra, Juan Diaz-Cartelle,

This prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA).The study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid ... Read more >>

Cardiovasc Intervent Radiol (Cardiovascular and interventional radiology)
[2015, 38(2):295-303]

Cited: 0 times

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Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study.

Horst Sievert, Joachim Schofer, John Ormiston, Uta C Hoppe, Ian T Meredith, Darren L Walters, Michel Azizi, Juan Diaz-Cartelle, Meital Cohen-Mazor,

<h4>Aims</h4>To evaluate the safety and efficacy of the balloon-based bipolar Vessix Renal Denervation System in treating patients with resistant hypertension.<h4>Methods and results</h4>In this prospective, multicentre, single-arm study, 146 patients (age 58.6±10.5 years; 61% men) with office systolic blood pressure (BP) ≥160 mmHg despite ≥3 antihypertensive medications at maximally tolerated doses ... Read more >>

EuroIntervention (EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology)
[2015, 10(10):1213-1220]

Cited: 14 times

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Revascularization of lower extremity chronic total occlusions with a novel intraluminal recanalization device: results of the ReOpen study.

Marc Bosiers, Juan Diaz-Cartelle, Dierk Scheinert, Patrick Peeters, Keith D Dawkins,

<h4>Purpose</h4>To report outcomes of a multicenter, nonrandomized study evaluating the safety and effectiveness of a guidewire-mounted mechanical recanalization device with a rotating distal tip (TruePath) in facilitating the crossing of infrainguinal chronic total occlusions (CTOs).<h4>Methods</h4>Eligible patients had lower extremity ischemia and an angiographically confirmed occlusion, with no antegrade flow for ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2014, 21(1):61-70]

Cited: 9 times

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Carotid artery stenting and patient outcomes: the CABANA surveillance study.

L Nelson Hopkins, Christopher J White, Malcolm T Foster, Richard J Powell, Gerald Zemel, Juan Diaz-Cartelle,

<h4>Objectives</h4>The purpose of the prospective, multicenter, nonrandomized CABANA study was to evaluate periprocedural clinical outcomes in high surgical risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EZ Embolic Protection System by a diverse group of clinicians.<h4>Background</h4>There is a need for additional evidence evaluating carotid artery ... Read more >>

Catheter Cardiovasc Interv (Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions)
[2014, 84(6):997-1004]

Cited: 5 times

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The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial.

Daniel G Clair, Julie Adams, Bernard Reen, Robert Feldman, Jean Starr, Juan Diaz-Cartelle, Keith D Dawkins,

<h4>Purpose</h4>To report the 1-year results of a pivotal study for a new-generation nitinol stent for the treatment of iliac atherosclerotic lesions.<h4>Methods</h4>The ORION trial (ClinicalTrials.gov identifier NCT00896337) was a single-arm, non-randomized, prospective, multicenter clinical trial that enrolled 125 patients (81 men; mean age 61.1±9.3 years) implanted with the EPIC self-expanding nitinol ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2014, 21(2):213-222]

Cited: 10 times

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Correlation between plasma osteopontin levels and aortic valve calcification: potential insights into the pathogenesis of aortic valve calcification and stenosis.

Pey-Jen Yu, Adam Skolnick, Giovanni Ferrari, Katherine Heretis, Paolo Mignatti, Giuseppe Pintucci, Barry Rosenzweig, Juan Diaz-Cartelle, Itzhak Kronzon, Gila Perk, Harvey I Pass, Aubrey C Galloway, Eugene A Grossi, Juan B Grau,

<h4>Objective</h4>The inflammatory process of aortic stenosis involves the differentiation of aortic valve myofibroblasts into osteoblasts. Osteopontin, a proinflammatory glycoprotein, both stimulates differentiation of myofibroblasts and regulates the deposition of calcium by osteoblasts. Osteopontin levels are increased in patients with such conditions as end-stage renal disease, ectopic calcification, and autoimmune disease. ... Read more >>

J Thorac Cardiovasc Surg (The Journal of thoracic and cardiovascular surgery)
[2009, 138(1):196-199]

Cited: 35 times

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Randomized comparison of 6-mm straight grafts versus 6- to 8-mm tapered grafts for brachial-axillary dialysis access.

Jose R Polo, Jose M Ligero, Juan Diaz-Cartelle, Rosario Garcia-Pajares, Teresa Cervera, Luis Reparaz,

<h4>Objective</h4>This report presents the results of a prospective randomized study that compared 2 grafts of different diameter: 6 mm, and 8 mm tapered to 6 mm at the arterial site, placed in the upper arm for hemodialysis in a selected population of patients younger than 71 years without diabetes.<h4>Methods</h4>Seventy consecutive ... Read more >>

J Vasc Surg (Journal of vascular surgery)
[2004, 40(2):319-324]

Cited: 12 times

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