NCT04640597

MIMICS-3D-USA Registry Study

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Veryan Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The MIMICS-3D-USA Study is a prospective, multicentre, observational study (non-investigational) of the BioMimics 3D Vascular Stent System that evaluates evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention for the treatment of peripheral artery disease.

Detailed description

The MIMICS-3D-USA Study is designed to enable the collection, analysis, reporting and presentation of data from use of the BioMimics 3D Vascular Stent System purchased by the hospital / institution or office interventional suite and used in accordance with the IFU associated with the product's FDA approval. The intent of this post-market observational study is to increase the understanding of the performance of the BioMimics 3D Vascular Stent System in a larger population of patients representative of a real-world situation within US hospitals, institutions and office-based interventional suites or labs.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	BioMimics 3D Vascular Stent System	Patients with BioMimics 3D Vascular Stent System

Timeline

• Start date: 2020-12-18
• Primary completion: 2023-09-04
• Completion: 2025-09-04
• First posted: 2020-11-23
• Last updated: 2022-11-16

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated device study