Last updated on March 2020

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions


Brief description of study

The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).

Detailed Study Description

BIOFLOW-VII is a prospective, multicenter, single-arm study. Subjects with coronary artery disease (CAD) who undergo an on-label percutaneous coronary intervention (PCI) with a placed Orsiro stent within the prior 24 hours will be screened post-index procedure per the protocol inclusion and exclusion criteria.

Following the index procedure and study enrollment, subjects will be followed for 5 years. The follow-up schedule will include an intermediate study visit at 1 month, a primary endpoint study visit at 12 months, and long-term study visits at 2, 3, 4, and 5 years.

Clinical Study Identifier: NCT04175626

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