A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Vascular Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D-USA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 26
- 主要终点
- Primary effectiveness endpoint of number of subjects of freedom from CEC Adjudicated clinically driven target lesion revascularization (CDTLR) through 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Primary effectiveness endpoint of number of subjects of freedom from CEC Adjudicated clinically driven target lesion revascularization (CDTLR) through 12 months
时间窗: 12 months
Freedom from CDTLR at 12 Months expressed as a percentage
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.
时间窗: 30 Days
Freedom from major adverse events expressed as a percentage
次要结局
- Procedural success defined as technical success with absence of MAE (comprising death,(24 hours after index procedure)
- Overall rate and incidence of adverse events(36 Months)
- Incidence of components of CEC-adjudicated MAE.(30 days, 12, 24 and 36 months)
- Incidence of stent fractures(36 Months)
- 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.(Procedural)
- Functional outcome: ankle brachial index measurement comparison(Baseline, within 30 days after index procedure, then at Month 12.)
- Primary Stent Patency rate determined by core lab adjudicated, duplex ultrasound at 12 Months(12 Months)
- Comparison of the quality of life (QoL) score at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36(Baseline, Day 30, Months 12, 24 and 36.)
- Comparison of mean Rutherford Clinical Category measured at Baseline, Day 30, Months 12, 24 and 36.(Baseline, Day 30, Months 12, 24 and 36.)