MIMICS-3D-USA Registry Study

Veryan Medical

Status: Active, not recruiting

Conditions: Peripheral Arterial Disease

Treatments: Device: BioMimics 3D Vascular Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT04640597

MIMICS-3D-USA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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