A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Self-Expanding Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 507
- 试验地点
- 23
- 主要终点
- Number of Participants Free From Major Adverse Events (MAE)
研究概览
简要总结
The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.
详细描述
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.
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 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)
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, 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.
结局指标
主要结局
Number of Participants Free From Major Adverse Events (MAE)
时间窗: 30 days
Primary Safety Endpoint: Number of participants free from a 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.
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CDTLR)
时间窗: 12 months
Primary Effectiveness Endpoint: Number of participants free from clinically-driven target lesion revascularization (CDTLR) through 12 months.
次要结局
- Number of Participants With a Final Residual Diameter Stenosis ≤30% at the End of the Index Procedure(Within 72 hours of the index procedure.)
- Number of Participants With Acute Technical Success and Absence of the Adverse Events Listed in the Description(Within 72 hours of index procedure.)
- Number of Participants With Adverse Events(30 day, 12 and 24 months)
- Stent Patency Rate(12 and 24 months.)
- Percent Probability of Individual Components of MAE(30 days, 12 Months, and 24 Months.)
- Comparison of Rutherford Clinical Category(Baseline, Day 30, 12 months and 24 months)
- Comparison of Ankle Brachial Index (ABI) Measurement(Baseline, Day 30, 12-month and 24-month.)
- Number of Participants With Reported Stent Fracture(30 day, 12 and 24 Months.)