<h2 id="hl0000211">Abstract</h2> <h2 id="hl0000213">Objectives</h2> <p id="hl0000214">To assess feasibility, safety and efficacy of hybrid approach, consisting in a combination of modern drug-eluting stent (DES) and drug-eluting balloon (DCB), for treatment of de-novo diffuse coronary artery disease (CAD).</p> <h2 id="hl0000216">Backgrounds</h2> <p id="hl0000217">Contemporary DES are associated with a persistent risk of major cardiovascular events, due to in-stent thrombosis and restenosis. The hybrid approach, reducing the permanent metallic cage length, is supposed to mitigate the risk of device-related adverse events, especially in diffuse CAD.</p> <h2 id="hl0000219">Methods</h2> <p id="hl0000220">This is a prospective, non-randomized, observational, multicenter study intended to obtain data from 100 consecutive patients affected by de-novo diffuse CAD undergoing percutaneous coronary intervention with a hybrid approach, consisting in the combined use of DES and DCB in contiguous coronary segments. The study is recorded in<span> </span><a id="hl0000221" href="http://clinicaltrials.gov/" target="_blank" rel="noopener"><i>ClinicalTrials.gov<span> </span></i></a>with the identifier:<span> </span><a id="hl0000223" href="http://clinicaltrials.gov/ct2/results?term=NCT03939468" target="_blank" rel="noopener">NCT03939468</a><span> </span>.</p> <h2 id="hl0000225">Results</h2> <p id="hl0000226">The primary endpoint is a device oriented composite end-point (DOCE) of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in DES- and/or DCB-treated segment. DOCE will be assessed at 12-months follow-up.</p> <h2 id="hl0000228">Conclusions</h2> <p id="hl0000229">This will be the first study investigating the feasibility, safety and efficacy of hybrid DES/DCB approach for the treatment of de-novo diffuse CAD. Here we describe the rationale and the design of the study.</p>