Efficacy and safety of novel multi-lumen catheter for chronic total occlusions: from preclinical study to first-in-man experience.
Catheter Cardiovasc Interv
; 85(3): E70-5, 2015 Feb 15.
Article
en En
| MEDLINE
| ID: mdl-25331940
ABSTRACT
OBJECTIVE:
To report our initial animal and human experience with a new multi-lumen catheter called MultiCross™ (Roxwood Medical, Inc.) in a porcine coronary model and patients with a chronic total occlusion (CTO).METHODS:
Preclinical safety study was done in the coronary vasculature of a porcine model. In a clinical setting, patients with a CTO of a coronary artery (n = 5) were enrolled. After an initial unsuccessful attempt using a conventional guidewire, operators could use the MultiCross system. The primary efficacy endpoint was successful recanalization (technical success) and the primary safety endpoint was serious adverse events through 30 days post-procedure.RESULTS:
The MultiCross catheter was used for all patients after failure of the initial attempt with a guidewire. Successful recanalization was achieved in all CTOs attempted (100%). No patients reported any adverse events at 30 days post-procedure.CONCLUSION:
In this first-in-man experience, the MultiCross catheter has the potential to enhance crossing of CTOs.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Cateterismo Cardíaco
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Oclusión Coronaria
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Catéteres Cardíacos
Tipo de estudio:
Diagnostic_studies
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Prognostic_studies
Límite:
Aged
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Animals
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2015
Tipo del documento:
Article