MIMICS-3D-USA Registry Study

Status unconfirmed

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT04640597

Run by

Veryan Medical Ltd.

People needed

500

Starts

2020-12-18

Expected to finish

2025-09-04

Last updated by the study team

2022-11-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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