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MIMICS-3D-USA Registry Study | Clinical Trials | Clareo Health

UNKNOWN

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

NCT04640597•Veryan Medical Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is age ≥18 and ≤85 years at the date of consent.
•Patient has provided written informed consent for participation in the study prior to index procedure.
•Patient has documented symptomatic peripheral arterial disease scheduled for treatment with the BioMimics 3D Vascular Stent System in accordance with the IFU.

Exclusion Criteria

•Patients whose lesions cannot be crossed with a wire and/or balloon catheter and cannot be dilated sufficiently to allow passage of the delivery system.
•Patients with a history of intolerance or adverse reaction to antiplatelet and/or anticoagulation therapies, bleeding diathesis or severe hypertension.
•Patients with known hypersensitivity to nickel-titanium.
•Patient has a comorbidity that in the Investigator's opinion would limit life expectancy to less than 12 months.
•Patient is pregnant or breastfeeding.
•Patient is unable or is unwilling to comply with site standard of care procedures

Locations (27)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

Cardiovascular Associates of the Southeast

Birmingham, Alabama, United States

Pulse Cardiovascular Institute

Scottsdale, Arizona, United States

Vascular Care Connecticut

Darien, Connecticut, United States

Cardiovascular Solutions Institute

Bradenton, Florida, United States

Palm Vascular Centers

Miami Beach, Florida, United States

Coastal Vascular & Interventional, PLLC

Pensacola, Florida, United States

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Coastal Vascular & Interventional, PLLC

Davenport, Iowa, United States

University of Iowa

Iowa City, Iowa, United States

Key Dates

Start Date

December 18, 2020

Primary Completion Date

September 4, 2023

Completion Date

September 4, 2025

Last Updated

November 16, 2022

Enrollment

500

ACTUAL participants

Conditions

Peripheral Arterial Disease

Interventions

BioMimics 3D Vascular Stent System

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

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Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

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RECRUITING

Advanta VXT and Flixene PMCF Registry

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Peripheral Arterial Disease

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MIMICS-3D-USA Registry Study

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

VITUS Post-Market Registry

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