NCT02163863

BioMimics 3D Stent Clinical Investigation: The Mimics Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Veryan Medical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary purpose of the Mimics Study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease.

Detailed description

The Mimics Study is a prospective, part randomized study; an initial roll-in registry of 10 subjects treated with BioMimics 3D followed by a randomized assignment to treatment with BioMimics 3D or Control on a 2:1 basis for 76 subjects. The primary purpose of the study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease based on: * Safety; measured by freedom from major adverse events determined at 30 days after the procedure, compared to historic controls. * Performance; measured by freedom from clinically driven TLR at 6 months, compared to historic controls.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Femoropopliteal stenting

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-10-01
• Completion: 2014-07-01
• First posted: 2014-06-16
• Last updated: 2019-11-14

Locations

1 site across 1 country: Germany