Registro nazionale bypass infrainguinale con l´utilizzo di bioprotesi Omniflow II

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Sinossi del registro nazionale bypass infrainguinale con l’utilizzo di bioprotesi Omniflow II ®

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Titolo

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Registro nazionale bypass infrainguinale con l’utilizzo di bioprotesi Omniflow II®

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Disegno

Raccolta dati su base volontaria mista retrospettiva/prospettica, non randomizzata, multicentrica, nazionale, basata sul concetto “all-comers”

Obiettivo

Valutare i risultati a breve, medio e lungo termine del bypass infrainguinale realizzato con l’utilizzo di bioprotesi Omniflow II® (LeMaitre Vascular Inc. Burlington, MA, USA)

Tecnica chirurgica

Bypass infrainguinale in bioprotesi Omniflow II® (LeMaitre Vascular Inc. Burlington, MA, USA) con anastomosi distale localizzata a livello dell’arteria poplitea sopragenicolare (above-the-knee, ATK), poplitea sottogenicolare (below-the-knee, BTK), del tronco tibioperoniero, di uno dei 3 vasi tibiali (arteria tibiale anteriore, arteria tibiale posteriore, arteria interossea) o di una delle arterie del piede

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Criteri di inclusione

Pazienti affetti da claudicatio intermittens invalidante a carico dell’arto index (classe Rutherford 3)
Pazienti affetti da ischemia critica dell’arto index in presenza di dolore a riposo e/o lesioni cutanee (classi Rutherford 4-5-6)
Eventuale presenza di concomitante infezione di pregresso bypass eseguito con materiale protesico (redo surgery)
Non disponibilità di vena safena autologa ipsilaterale all’arto index o diametro minimo della vena safena inferiore a 1.6 mm
Anastomosi distale localizzata a livello dell’arteria poplitea sopragenicolare, poplitea sottogenicolare, del tronco tibioperoniero, di uno dei 3 vasi tibiali (arteria tibiale anteriore, arteria tibiale posteriore, arteria interossea) o di una delle arterie del pied
Età maggiore di 18 anni

Criteri di esclusione

Pazienti affetti da claudicatio intermittens non invalidante (classi Rutherford 1-2)
Pazienti affetti da patologia dilatativa degli arti inferiori

Periodo di arruolamento della fase retrospettiva

Tutti gli interventi eseguiti da Gennaio 2019 a Dicembre 2021 (3 anni)

Numero di pazienti da arruolare per la fase retrospettiva

150 Periodo di arruolamento della fase prospettica

Tutti gli interventi eseguiti da Gennaio 2022 a Dicembre 2023 (2 anni)

Numero di pazienti da arruolare per la fase prospettica

150 Data presunta di inizio arruolamento fase prospettica

Gennaio 2022

Numero totale di pazienti da arruolare

300 Durata totale dello studio

2 anni per arruolamento fase prospettica + ulteriori 2 anni di follow-up (fine presunta dello studio Dicembre 2025)

Tempistiche per l’osservazione

Arruolamento previa valutazione clinica ed ecocolorDoppler ed eventuale diagnostica di secondo livello (angio-TC/angio-RM), procedura, dimissione con valutazione clinica ed ecocolorDoppler, 1 mese, 6 mesi, 12 mesi e 24 mesi

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Outcomes primari dello studio

Pervietà primaria
Pervietà primaria assistita
Pervietà secondaria
Salvataggio d’arto

Outcomes secondari dello studio

Miglioramento di almeno 1 classe di Rutherford
Tasso di infezioni
Confronto de novo lesion vs. post-endo lesion
Confronto sede anastomotica distale (sopragenicolare vs. sottogenicolare vs. vasi tibiali)

Analisi statistica

Raccolta dati su piattaforma online e successiva creazione di apposito database su programma SPSS per l’elaborazione statistica
Valutazione degli outcomes con analisi univariata (curve di Kaplan-Meier) e multivariata (regressione di Cox) dei fattori influenzanti i risultati con stime dei risultati a 1, 3 e 5 anni (breve, medio e lungo termine)

Proprietà dati

Tutti i centri partecipanti sotto l’egida della Società Italiana di Chirurgia vascolare ed Endovascolare (SICVE)

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DOWNLOAD DOCUMENTI CORRELATI

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Il Registro

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Sinossi del registro nazionale bypass infrainguinale con l’utilizzo di bioprotesi Omniflow II ®

Titolo

Registro nazionale bypass infrainguinale con l’utilizzo di bioprotesi Omniflow II®

Disegno

Raccolta dati su base volontaria mista retrospettiva/prospettica, non randomizzata, multicentrica, nazionale, basata sul concetto “all-comers”

Obiettivo

Valutare i risultati a breve, medio e lungo termine del bypass infrainguinale realizzato con l’utilizzo di bioprotesi Omniflow II® (LeMaitre Vascular Inc. Burlington, MA, USA)

Tecnica chirurgica

Criteri di inclusione

Pazienti affetti da claudicatio intermittens invalidante a carico dell’arto index (classe Rutherford 3)

Pazienti affetti da ischemia critica dell’arto index in presenza di dolore a riposo e/o lesioni cutanee (classi Rutherford 4-5-6)

Eventuale presenza di concomitante infezione di pregresso bypass eseguito con materiale protesico (redo surgery)

Non disponibilità di vena safena autologa ipsilaterale all’arto index o diametro minimo della vena safena inferiore a 1.6 mm

Anastomosi distale localizzata a livello dell’arteria poplitea sopragenicolare, poplitea sottogenicolare, del tronco tibioperoniero, di uno dei 3 vasi tibiali (arteria tibiale anteriore, arteria tibiale posteriore, arteria interossea) o di una delle arterie del pied

Età maggiore di 18 anni

Criteri di esclusione

Pazienti affetti da claudicatio intermittens non invalidante (classi Rutherford 1-2)

Pazienti affetti da patologia dilatativa degli arti inferiori

Periodo di arruolamento della fase retrospettiva

Tutti gli interventi eseguiti da Gennaio 2019 a Dicembre 2021 (3 anni)

Numero di pazienti da arruolare per la fase retrospettiva

150

Periodo di arruolamento della fase prospettica

Tutti gli interventi eseguiti da Gennaio 2022 a Dicembre 2023 (2 anni)

Numero di pazienti da arruolare per la fase prospettica

150

Data presunta di inizio arruolamento fase prospettica

Gennaio 2022

Numero totale di pazienti da arruolare

300

Durata totale dello studio

2 anni per arruolamento fase prospettica + ulteriori 2 anni di follow-up (fine presunta dello studio Dicembre 2025)

Tempistiche per l’osservazione

Arruolamento previa valutazione clinica ed ecocolorDoppler ed eventuale diagnostica di secondo livello (angio-TC/angio-RM), procedura, dimissione con valutazione clinica ed ecocolorDoppler, 1 mese, 6 mesi, 12 mesi e 24 mesi

Outcomes primari dello studio

Pervietà primaria

Pervietà primaria assistita

Pervietà secondaria

Salvataggio d’arto

Outcomes secondari dello studio

Miglioramento di almeno 1 classe di Rutherford

Tasso di infezioni

Confronto de novo lesion vs. post-endo lesion

Confronto sede anastomotica distale (sopragenicolare vs. sottogenicolare vs. vasi tibiali)

Analisi statistica

Raccolta dati su piattaforma online e successiva creazione di apposito database su programma SPSS per l’elaborazione statistica

Valutazione degli outcomes con analisi univariata (curve di Kaplan-Meier) e multivariata (regressione di Cox) dei fattori influenzanti i risultati con stime dei risultati a 1, 3 e 5 anni (breve, medio e lungo termine)

Proprietà dati

Tutti i centri partecipanti sotto l’egida della Società Italiana di Chirurgia vascolare ed Endovascolare (SICVE)