MIMICS-3D-USA Registry Study

NCT04640597 | Unknown DMC FDA Device

• 1 other identifier: MIMICS-3D-USA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

PAD; PVD; SFA stent; stent; Helical stent; Vascular stent

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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.

  Procedural

• Procedural success defined as technical success with absence of MAE (comprising death,

  24 hours after index procedure

• Incidence of components of CEC-adjudicated MAE.

  30 days, 12, 24 and 36 months

• Overall rate and incidence of adverse events

  36 Months

• Primary Stent Patency rate determined by core lab adjudicated, duplex ultrasound at 12 Months

  12 Months

Interventions

BioMimics 3D Vascular Stent System DEVICE

Patients with BioMimics 3D Vascular Stent System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Veryan Medical Ltd.: lead

Study Sites (27)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Cardiovascular Associates of the Southeast

Birmingham, Alabama, 35243, United States

Location

Pulse Cardiovascular Institute

Scottsdale, Arizona, 85251, United States

Location

Vascular Care Connecticut

Darien, Connecticut, 06820, United States

Location

Cardiovascular Solutions Institute

Bradenton, Florida, 34208, United States

Location

Palm Vascular Centers

Miami Beach, Florida, 33140, United States

Location

Coastal Vascular & Interventional, PLLC

Pensacola, Florida, 32504, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52801, United States

Location

Coastal Vascular & Interventional, PLLC

Davenport, Iowa, 52807, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

CIS Clinical Research Corporation

Houma, Louisiana, 70360, United States

Location

Vascular Care Group

Wellesley, Massachusetts, 02482, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

NJ Endovascular and Amputation Prevention, LLP

Clifton, New Jersey, 07013, United States

Location

Cardiac And Vascular Interventions of NJ

New Brunswick, New Jersey, 08901, United States

Location

Columbia University Irving Medical Center/NYPH

New York, New York, 10032, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Amputation Prevention Center of North Carolina

Cary, North Carolina, 27518, United States

Location

Advanced Cardiovascular Solutions

Oklahoma City, Oklahoma, 73134, United States

Location

US cardiovascular of Greenburg

Jefferson Hills, Pennsylvania, 15025, United States

Location

Ascension Seton Heart Institute

Austin, Texas, 78705, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

Baylor St Lukes Medical Center

Houston, Texas, 77030, United States

Location

North Dallas Research Associates

McKinney, Texas, 75609, United States

Location

Hurricane Cardiology Research

New Braunfels, Texas, 78130, United States

Location

AZH Wound & Vascular Center

Milwaukee, Wisconsin, 53221, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Nuwani Edirisinghe

  Veryan Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 23, 2020
• Study Start: December 18, 2020
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2025
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)