NCT02400905

Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Veryan Medical Ltd. · Industry
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	BioMimics 3D Vascular Stent System	Femoropopliteal stenting

Timeline

• Start date: 2015-06-29
• Primary completion: 2017-11-03
• Completion: 2019-12-03
• First posted: 2015-03-27
• Last updated: 2021-06-04
• Results posted: 2019-01-18

Locations

43 sites across 3 countries: United States, Germany, Japan