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Clinical Trial Summary

A Pilot Observational Study to evaluate safety and efficacy of the hybrid approach DES/DCB in treating de-novo diffuse lesions


Clinical Trial Description

This is a prospective, non-randomized, single-arm, multi-center, pilot, noninterventional study whose aim is to assess the feasibility and the clinical outcomes of using the Restore DCB (Cardionovum GmbH, Bonn, Germany) in combination ("hybrid approach") with a new generation DES (type at operator's discretion) for the treatment of diffuse CAD encountered in daily clinical practice. The rationale of the proposed strategy derives from the characteristics of DCB in treating the atherosclerotic disease without leaving a permanent structure in the vessel especially in case of diffuse CAD -avoiding a long metallic, permanent cage within extended coronary segments ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03939468
Study type Observational [Patient Registry]
Source Istituto Clinico Sant'Ambrogio
Contact
Status Not yet recruiting
Phase
Start date May 1, 2019
Completion date June 1, 2021

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