A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter for the Endovascular Interventions in the Ilio-femoropopliteal Vessels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 387
- 试验地点
- 9
- 主要终点
- Freedom from Serious Adverse Events
研究概览
简要总结
The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is >18 years old at conduction of the procedure.
- •Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at least one of the following the S.M.A.R.T. Flex Stent Iliac and/or S.M.A.R.T. Flex SFA/PP and/or S.M.A.R.T. Control Nitinol Stent and/or S.M.A.R.T. Nitinol Stent and/or PALMAZ Blue .018 Peripheral Stent on Slalom and/or PALMAZ Genesis .035 Peripheral Stent on Opta Pro and/or SABER OTW PTA Catheter and/or SABERX PTA Dilatation Catheter and/or PowerFlex Pro PTA Catheter as described in the IFU of the devices.
- •Target Lesion is located in the ilio-femoropopliteal vessels.
排除标准
- •Anatomy or size of vessels that did not allow appropriate usage of the devices, following IFU of the devices.
- •Known contraindication and/or allergy to (a component of) the device as described in the IFU of the devices.
- •Women who were pregnant or lactating at the time of the procedure.
- •Life expectancy of less than 12 months at the time of procedure.
- •Any patient who was hemodynamically unstable at onset of procedure.
结局指标
主要结局
Freedom from Serious Adverse Events
时间窗: 12 months
Primary Safety Endpoint: Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) up to 12 months after the procedure.
Technical success rate
时间窗: During the procedure
Acute Primary Efficacy Endpoint: Technical success rate defined as successful crossing, introduction, deployment (stents)/deflation (balloon catheter) and a \<30% residual stenosis on visual assessment of S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter according to the respective IFU.
Freedom from clinically-driven target lesion revascularization
时间窗: 12 months
Primary Efficacy Endpoint: The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any reintervention at the target lesion due to symptoms.
次要结局
- Stent migration rate(Up to 30 days post-procedure, 12-, 36- and 60-months)
- Freedom from CD-TLR(36- and 60-months)
- Rate of Major Amputation free survival(Up to 30 days post-procedure, 12-, 36- and 60-months)
- All cause of mortality(procedure through study completion (12 months))
- Time-to-hemostasis(Day of procedure)
- Time-to-ambulation(Day of procedure)
- Vessel perforation/dissection(During the procedure)
- Technical success rate(Day of procedure)
- Stent fracture rate(Up to 30 days post-procedure, 12-, 36- and 60-months)
- Clinical success(Up to 30 days post-procedure, 12-, 36- and 60-months)
- Change of Ankle Brachial Index(Up to 30 days post-procedure, 12-, 36- and 60-months)
- Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)(36- and 60-months)