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Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease — HYPER II  

Coronary Artery Disease Clinical Trial

Official title:
A Hybrid Approach Evaluating A Drug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease: The HYPER II Study

Clinical Trial Summary

An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease

Clinical Trial Description

This is a prospective, non-randomized, single-arm, multi-center study aiming 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 (Coronary Artery Disease) encountered in daily clinical practice (lesion length > 38 mm). 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

Clinical Trial Details
NCT number NCT05650450
Study type Observational [Patient Registry]
Source I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Contact
Status Enrolling by invitation
Phase
Start date May 1, 2022
Completion date January 1, 2025
View Details
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