MIMICS-3D-USA Registry Study

Conditions

• Peripheral Arterial Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• BioMimics 3D Vascular Stent System — DEVICE
  Patients with BioMimics 3D Vascular Stent System

Study Details

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.

Key Dates

First listed

Nov 23, 2020

Start date

Dec 18, 2020

Status verified

Nov 2022

Primary completion

Sep 4, 2023

Completion

Sep 4, 2025

Study Design

Enrollment

500 participants (actual)

Primary Outcome Measure

Safety endpoint of number of subjects of freedom from CEC-adjudicated major adverse events (MAE) comprising death, any unplanned major amputation performed on the index limb or clinically driven target lesion revascularization (CDTLR) through 30 days. [ Time Frame: 30 Days ]

Locations (27)

Find similar trials in Birmingham, AL

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