MIMICS-3D-USA Registry Study

NCT ID: NCT04640597

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2025-09-04

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.

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.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

BioMimics 3D Vascular Stent System

Patients with BioMimics 3D Vascular Stent System

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veryan Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nuwani Edirisinghe

Role: STUDY_DIRECTOR

Veryan Medical

Locations

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

CIS Clinical Research Corporation

Houma, Louisiana, United States

Vascular Care Group

Wellesley, Massachusetts, United States

University of Missouri

Columbia, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

NJ Endovascular and Amputation Prevention, LLP

Clifton, New Jersey, United States

Cardiac And Vascular Interventions of NJ

New Brunswick, New Jersey, United States

Columbia University Irving Medical Center/NYPH

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Amputation Prevention Center of North Carolina

Cary, North Carolina, United States

Advanced Cardiovascular Solutions

Oklahoma City, Oklahoma, United States

US cardiovascular of Greenburg

Jefferson Hills, Pennsylvania, United States

Ascension Seton Heart Institute

Austin, Texas, United States

Cardiothoracic and Vascular Surgeons

Austin, Texas, United States

Baylor St Lukes Medical Center

Houston, Texas, United States

North Dallas Research Associates

McKinney, Texas, United States

Hurricane Cardiology Research

New Braunfels, Texas, United States

AZH Wound & Vascular Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

MIMICS-3D-USA

Identifier Type: -

Identifier Source: org_study_id