MIMICS-3D-USA Registry Study

November 15, 2022 updated by: Veryan Medical Ltd.

A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Vascular Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D-USA

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics, LLC
      • Birmingham, Alabama, United States, 35243
        • Cardiovascular Associates of the Southeast
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Pulse Cardiovascular Institute
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Vascular Care Connecticut
    • Florida
      • Bradenton, Florida, United States, 34208
        • Cardiovascular Solutions Institute
      • Miami Beach, Florida, United States, 33140
        • Palm Vascular Centers
      • Pensacola, Florida, United States, 32504
        • Coastal Vascular & Interventional, PLLC
    • Iowa
      • Davenport, Iowa, United States, 52801
        • Midwest Cardiovascular Research Foundation
      • Davenport, Iowa, United States, 52807
        • Coastal Vascular & Interventional, PLLC
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • CIS Clinical Research Corporation
    • Massachusetts
      • Wellesley, Massachusetts, United States, 02482
        • Vascular Care Group
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • NJ Endovascular and Amputation Prevention, LLP
      • New Brunswick, New Jersey, United States, 08901
        • Cardiac And Vascular Interventions of NJ
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical center
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center/NYPH
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Amputation Prevention Center of North Carolina
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73134
        • Advanced Cardiovascular Solutions
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, United States, 15025
        • US cardiovascular of Greenburg
    • Texas
      • Austin, Texas, United States, 78756
        • Cardiothoracic and Vascular Surgeons
      • Austin, Texas, United States, 78705
        • Ascension Seton Heart Institute
      • Houston, Texas, United States, 77030
        • Baylor St Lukes Medical Center
      • McKinney, Texas, United States, 75609
        • North Dallas Research Associates
      • New Braunfels, Texas, United States, 78130
        • Hurricane Cardiology Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53221
        • AZH Wound & Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who receive treatment with Veryan's BioMimics 3D Vascular Stent System in accordance with the current approved FDA (PMA # 180003 approval) indication for use as stated in the Instructions for Use (IFU) will be consecutively enrolled in this study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Freedom from major adverse events expressed as a percentage
30 Days
Primary effectiveness endpoint of number of subjects of freedom from CEC Adjudicated clinically driven target lesion revascularization (CDTLR) through 12 months
Time Frame: 12 months
Freedom from CDTLR at 12 Months expressed as a percentage
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success defined as delivery and deployment of the study stent to achieve a final residual diameter stenosis of ≤30% measured by visual assessment of angiographic imaging at the end of the study procedure on Day 0.
Time Frame: Procedural
Number of participants with final residual stenosis ≤30%
Procedural
Procedural success defined as technical success with absence of MAE (comprising death,
Time Frame: 24 hours after index procedure
Number of participants with acute technical success and absence of MAE
24 hours after index procedure
Incidence of components of CEC-adjudicated MAE.
Time Frame: 30 days, 12, 24 and 36 months
Incidence of individual components of CEC-adjudicated MAE (death, any unplanned major amputation performed on the index limb or CDTLR).
30 days, 12, 24 and 36 months
Overall rate and incidence of adverse events
Time Frame: 36 Months
Overall rate and incidence of adverse events from Day 0 to completion of study follow-up at month 36
36 Months
Primary Stent Patency rate determined by core lab adjudicated, duplex ultrasound at 12 Months
Time Frame: 12 Months
Primary Stent Patency expressed as a percentage
12 Months
Comparison of mean Rutherford Clinical Category measured at Baseline, Day 30, Months 12, 24 and 36.
Time Frame: Baseline, Day 30, Months 12, 24 and 36.
Compare RCC at each of the follow-up visit with the Baseline
Baseline, Day 30, Months 12, 24 and 36.
Functional outcome: ankle brachial index measurement comparison
Time Frame: Baseline, within 30 days after index procedure, then at Month 12.
Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Month 12.
Baseline, within 30 days after index procedure, then at Month 12.
Comparison of the quality of life (QoL) score at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36
Time Frame: Baseline, Day 30, Months 12, 24 and 36.
Compare the change in QoL score compared to the Baseline
Baseline, Day 30, Months 12, 24 and 36.
Incidence of stent fractures
Time Frame: 36 Months
Incidence of reported stent fracture reported by investigational sites through 36 months
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Veryan Medical Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nuwani Edirisinghe, Veryan Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MIMICS-3D-USA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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