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Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels — TRANSFORM II  

Coronary Artery Disease Clinical Trial

Official title:
Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels

Clinical Trial Summary

International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).

Clinical Trial Description

The purpose of TRANSFORM II study is to observe and evaluate the efficacy of Magic Touch SCB compared to the gold standard treatment for native vessel disease, namely new-generation everolimus-eluting Drug Eluting Stent (DES). Given the inherent and recognized limitations of stents in native vessels with diameter <3 mm, only patients with coronary vessels up to 3.5 mm of diameter (by visual estimation) will be enrolled in this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04893291
Study type Interventional
Source Fondazione Ricerca e Innovazione Cardiovascolare ETS
Contact Bernardo Cortese, Dr.
Phone +39 348 1123968
Email bcortese@gmail.com
Status Recruiting
Phase N/A
Start date November 16, 2021
Completion date November 30, 2028
View Details
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