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

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: Active, not recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: BioMimics 3D Vascular Stent System

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: Observational
• Enrollment (Actual): 500

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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.	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	Freedom from CDTLR at 12 Months expressed as a percentage	12 months

Secondary Outcome Measures

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.	Number of participants with final residual stenosis ≤30%	Procedural
Procedural success defined as technical success with absence of MAE (comprising death,	Number of participants with acute technical success and absence of MAE	24 hours after index procedure
Incidence of components of CEC-adjudicated MAE.	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	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	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.	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	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	Compare the change in QoL score compared to the Baseline	Baseline, Day 30, Months 12, 24 and 36.
Incidence of stent fractures	Incidence of reported stent fracture reported by investigational sites through 36 months	36 Months

Collaborators and Investigators

• Sponsor: Veryan Medical Ltd.
• Investigators: Study Director: Nuwani Edirisinghe, Veryan Medical

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Anticipated): September 4, 2023
• Study Completion (Anticipated): September 4, 2025

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: PAD; stent; PVD; SFA stent; Helical stent; Vascular stent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID 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