Peripheral Arterial Disease Clinical Trial
Official title:
A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Self-Expanding Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D
The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.
The MIMICS-3D study is a prospective, multicentre, observational study of the BioMimics 3D
Stent System in patients undergoing endovascular intervention to relieve symptomatic
peripheral arterial disease of the femoropopliteal artery. The study is designed to enable
the collection, analysis and reporting of data from "real-world" use of the BioMimics 3D
Stent System used in accordance with the Instructions for Use (IFU) associated with the
product's CE Mark approval.
Data collection will include that relating to safety, effectiveness and device performance
and the period of observation during which data will be collected will extend from the index
procedure through 3 years (36 months), according to the standard follow-up practice of the
enrolling institution.
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