NCT02900924

Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D

A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Self-Expanding Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 507 (actual)
• Sponsor: Veryan Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.

Detailed description

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	BioMimics 3D Stent

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-10-01
• Completion: 2021-09-01
• First posted: 2016-09-15
• Last updated: 2025-04-17
• Results posted: 2025-04-17

Locations

23 sites across 4 countries: Belgium, Germany, Netherlands, Sweden