MIMICS-3D-USA Registry Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Vascular Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D-USA

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: BioMimics 3D Vascular Stent System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BioMimics 3D Vascular Stent System|Patients with BioMimics 3D Vascular Stent System|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, PVD, SFA stent, stent, Helical stent, Vascular stent