Coronary Artery Disease Clinical Trial
Official title:
Direct Implantation of Sirolimus-Eluting Stents With Bioresorbable Drug Carrier Technology Utilizing the Svelte Drug-Eluting Coronary Stent: The Direct III Post Market Study
The primary objective of this multicenter, single-arm, observational study is to evaluate the feasibility of a systematic direct stenting strategy with the Svelte SLENDER IDS Sirolimus-Eluting Coronary Stent-on-a-Wire Integrated Delivery System (SLENDER IDS) in an all-comers, real-world population.
In this post-market study, the population will include real-world subjects who are intended
to be treated, with SLENDER IDS as standard therapy. Follow-up contacts post procedure will
be made for clinical assessments at hospital discharge, 1, 6 and 12 months.
This study is designed as a prospective, multi-center, single-arm, observational all-comers
clinical study to collect ongoing safety and efficacy of SLENDER IDS and to determine the
feasibility of a direct stenting strategy in an all-comers population. A minimum of two
hundred fifty (250) subjects will be treated at up to 20 sites in Europe.
Review of safety data and risks to subjects will be monitored by an independent Clinical
Events Committee (CEC) at pre-specified enrollment milestones.
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