The Indigo System in acute lower-limb malperfusion (INDIAN) registry. Protocol
| Title: | The Indigo System in acute lower-limb malperfusion (INDIAN) registry. Protocol |
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| Authors: | Gianmarco de Donato; Edoardo Pasqui; Giovanni Giannace; Francesco Setacci; Domenico Benevento; Giancarlo Palasciano; Carlo Setacci; INDIAN Registry Collaborators; Leonardo Ercolini; Massimo Pieraccini; Giuseppe Galzerano; Stefano Michelagnoli; Emiliano Chisci; Nicola Troisi; Denis Rossato; Antonella Ruffino; Andrea Di Scalzi; Andrea Mancini; Franco Nessi; Andrea Gaggiano; Michelangelo Ferri; Andrea Viazzo; Daniele Savio; Luca di Maggio; Chiara Comelli; Massimiliano Natrella; Domenico Palombo; Spinella Giovanni; Giovanni Pratesi; Bianca Pane; Angelo Spinazzola; Aldo Arzini; Luca Boccalon; Giuseppe Guzzardi; Raffaele Cuomo; Marco Ravanelli; Massimiliano Bonera; Pietro Quaretti; Lorenzo Moramarco; Nicola Cionfoli; Stefano Pirrelli; Maurizio Cariati; Davide Santuari; Gianpaolo Carrafiello; Antonio Rampoldi; Gian Luca Canu; Massimo Sponza; Tommaso Gorgatti; Antonio Jannello; Luca Garriboli; Francesco Speziale; Wassim Mansour; Pasqualino Sirignano; Massimo Lenti; Giacomo Isernia; Gioele Simonte; Arnaldo Ippoliti; Gianluca Citoni; Pierfrancesco Veroux; Alessia Giaquinta; Pierluigi Cappiello; Andrea Esposito; Francesco Intrieri; Paolo Perri; Vincenzo Molinari; Antonio Esposito; Vincenzo Pestrichella; Domenico Patanè; Emanuela Gianpalma; Antono Freyrie; Domenico Palmarini; Roberto Silingardi; Antonio Lauricella; Andrea Stella; Mauro Gargiulo; Raffaele Pulli; Davide Marinazzo; Nicola Mangialardi; Sonia Ronchey; Stefano Fazzini; Matteo Orrico; Stefano Barbero; Stefano Camparini; Eugenio Stabile; Carlo Ruotolo; Ilaria Ficarelli; Gabriele Maritati; Giorgio Sbenaglia; Giovanni Passalacqua; Simone Comelli; Stefano Bartoli; Andrea Siani; Federico Accrocca; Franco Zandrino; Ivan Gallesio; Alessandro Cappelli; Claudio Baldi; Mariagnese Mele; Claudia Panzano; Giuseppe Alba; Gaia Grottola; Pela Bisatti; Brenda Brancaccio |
| Contributors: | de Donato, Gianmarco; Pasqui, Edoardo; Giannace, Giovanni; Setacci, Francesco; Benevento, Domenico; Palasciano, Giancarlo; Setacci, Carlo; Registry Collaborators, Indian; Ercolini, Leonardo; Pieraccini, Massimo; Galzerano, Giuseppe; Michelagnoli, Stefano; Chisci, Emiliano; Troisi, Nicola; Rossato, Deni; Ruffino, Antonella; Di Scalzi, Andrea; Mancini, Andrea; Nessi, Franco; Gaggiano, Andrea; Ferri, Michelangelo; Viazzo, Andrea; Savio, Daniele; di Maggio, Luca; Comelli, Chiara; Natrella, Massimiliano; Palombo, Domenico; Giovanni, Spinella; Pratesi, Giovanni; Pane, Bianca; Spinazzola, Angelo; Arzini, Aldo; Boccalon, Luca; Guzzardi, Giuseppe; Cuomo, Raffaele; Ravanelli, Marco; Bonera, Massimiliano; Quaretti, Pietro; Moramarco, Lorenzo; Cionfoli, Nicola; Pirrelli, Stefano; Cariati, Maurizio; Santuari, Davide; Carrafiello, Gianpaolo; Rampoldi, Antonio; Luca Canu, Gian; Sponza, Massimo; Gorgatti, Tommaso; Jannello, Antonio; Garriboli, Luca; Speziale, Francesco; Mansour, WASSIM AHMAD; Sirignano, Pasqualino; Lenti, Massimo; Isernia, Giacomo; Simonte, Gioele; Ippoliti, Arnaldo; Citoni, Gianluca; Veroux, Pierfrancesco; Giaquinta, Alessia; Cappiello, Pierluigi; Esposito, Andrea; Intrieri, Francesco; Perri, Paolo; Molinari, Vincenzo; Esposito, Antonio; Pestrichella, Vincenzo; Patanè, Domenico; Gianpalma, Emanuela; Freyrie, Antono; Palmarini, Domenico; Silingardi, Roberto; Lauricella, Antonio; Stella, Andrea; Gargiulo, Mauro; Pulli, Raffaele; Marinazzo, Davide; Mangialardi, Nicola; Ronchey, Sonia; Fazzini, Stefano; Orrico, Matteo; Barbero, Stefano; Camparini, Stefano; Stabile, Eugenio; Ruotolo, Carlo; Ficarelli, Ilaria; Maritati, Gabriele; Sbenaglia, Giorgio; Passalacqua, Giovanni; Comelli, Simone; Bartolini, Stefano; Siani, Andrea; Accrocca, Federico; Zandrino, Franco; Gallesio, Ivan; Cappelli, Alessandro; Baldi, Claudio; Mele, Mariagnese; Panzano, Claudia; Alba, Giuseppe |
| Publisher Information: | J M I R Publications, Inc.; Toronto |
| Publication Year: | 2019 |
| Collection: | Sapienza Università di Roma: CINECA IRIS |
| Subject Terms: | acute limb ischemia; endovascular; mechanical thrombectomy |
| Description: | Background: Acute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis. Objective: The devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions. Methods: This study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month. Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will ... |
| Document Type: | article in journal/newspaper |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/30869648; info:eu-repo/semantics/altIdentifier/wos/WOS:000462890300031; volume:8; issue:3; numberofpages:6; journal:JMIR RESEARCH PROTOCOLS; http://hdl.handle.net/11573/1411283 |
| DOI: | 10.2196/resprot.9972 |
| Availability: | http://hdl.handle.net/11573/1411283; https://doi.org/10.2196/resprot.9972 |
| Rights: | info:eu-repo/semantics/openAccess |
| Accession Number: | edsbas.8E95C03F |
| Database: | BASE |