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Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System — MIMICS-2  

Peripheral Arterial Disease Clinical Trial

Official title:
MIMICS-2: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System in the Femoropopliteal Arteries of Patients With Symptomatic Peripheral Arterial Disease

Clinical Trial Summary

To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm, multicenter clinical trial.

Clinical Trial Description

The BioMimics 3D stent is intended to improve luminal diameter in the treatment of symptomatic de-novo, obstructive or occlusive lesions in native femoropopliteal arteries with reference vessel diameters ranging from 4.0 - 6.0 mm. Subjects with symptomatic atherosclerotic disease of the femoropopliteal artery who comply with all study eligibility criteria may be considered for enrollment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02400905
Study type Interventional
Source Veryan Medical Ltd.
Contact
Status Completed
Phase N/A
Start date June 29, 2015
Completion date December 3, 2019
View Details
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