At a glance
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Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With de Novo Coronary Artery Lesion (NeoVas): a First-in-Man Study
In Brief
A Phase 1 clinical trial evaluating NeoVas BCS for Coronary Artery Disease. Targeting 31 participants across 2 sites.
Detailed Summary
The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion.
Study Details
Timeline
Interventions
The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and ischemia driven target lesion revascularization (TLF) at 1 month follow up. At 6 months, 1, 2, 3, 4 and 5 years follow-up, clinical endpoints include TLF (its individual components), Patient-oriented cardiac event (all cause death, all MI, and all revascularization) target vessel revascularization, scaffold thrombosis.