Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D

Study Overview
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Brief Summary
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The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.

Detailed Description
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The MIMICS-3D study is a prospective, multicentre, observational study of the BioMimics 3D Stent System in patients undergoing endovascular intervention to relieve symptomatic peripheral arterial disease of the femoropopliteal artery. The study is designed to enable the collection, analysis and reporting of data from real-world use of the BioMimics 3D Stent System used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval. Data collection will include that relating to safety, effectiveness and device performance and the period of observation during which data will be collected will extend from the index procedure through 3 years (36 months), according to the standard follow-up practice of the enrolling institution.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: BioMimics 3D Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is age ≥18 and ≤85 years at 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 stent in accordance with the approved CE Mark indication and Instructions for Use (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, severe hypertension or renal failure. 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 and follow-up visit schedules for patients undergoing femoropopliteal intervention.

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 Stent|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from a composite of major adverse events (MAE) (Primary Safety Endpoint) | Number of participants free from composite of major adverse events (MAE) comprising death, any major amputation performed on the index limb or clinically-driven target lesion revascularization (CDTLR) through 30 days. | 30 days | 
| Freedom from clinically-driven target lesion revascularization (CDTLR) (Primary Effectiveness Endpoint) | Number of participants free from clinically-driven target lesion revascularization (CDTLR) through 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute technical success defined as achievement of a final residual diameter stenosis ≤30% at the end of the procedure | Number of participants with final residual diameter stenosis ≤30% at the end of the index procedure | Procedural | 
| Acute procedural success defined as acute technical success and absence of peri-procedural adverse events. | Number of participants with acute technical success and absence of the following adverse events: death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery, within 72 h of the index procedure. | 72 hours | 
| Incidence of individual components of MAE | Incidence of individual components of MAE (death, any major amputation performed on the index limb or CDTLR) through 36 months | 30 days, 12, 24 and 36 months | 
| Overall rate and incidence of adverse events from Day 0 through completion of study follow-up at Month 36. | Overall rate and incidence of all adverse events reported from Day 0 through completion of study follow-up at Month 36. | 36 months | 
| Stent patency | Stent patency rate assessed by duplex ultrasound, as available, determined at Months 12, 24 and 36. This will be assessed using values of peak systolic velocity ratio (PSVR) >2.0, >2.4; >2.5; and >3.5 each to indicate loss of patency on duplex ultrasound. | 12, 24 and 36 months | 
| Rutherford Clinical Category | Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 24 and 36. | Baseline, Day 30, Months 12 24 and 36 | 
| Functional outcome (ankle brachial index (ABI) measurement) | Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36. | Baseline, Day 30, Months 12, 24 and 36. | 

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