NCT05447052

The Biomimetic Stent and Vascular Functions Study

The Biomimetic Stent and Vascular Functions Study-The MIMICS FLOW STUDY

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this IIT is to determine the potential improvement and impact of the BioMimics 3D Stent System in the SFA on local vascular function.

Detailed description

The MIMICS FLOW Study is a single-center, single-blind, investigator-initiated, randomized parallel group trial. The impact of a novel biomimetical stent with a helical curvature provides superior hemodynamic and biomechanical performance and advantages. Additionally, it promotes swirling blood flow, elevating wall sheer strength, which is patency-protective and might impact on vascular functions due to completely different vascular properties through altered blood flow. The influence of the novel devices and stent-platforms with improved hemodynamic capabilities with respect to vasomotor of the vessel wall, vascular function and vascular compliance can be measured by FMD, arterial stiffness indices and vascular strain analysis.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Bio-MIMICS 3D Stent	Bio-MIMICS Stent implantation
DEVICE	Innova Stent	Innova Stent implantation

Timeline

• Start date: 2021-04-26
• Primary completion: 2024-04-26
• Completion: 2025-04-26
• First posted: 2022-07-07
• Last updated: 2023-12-05

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study