A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Number of Lesions With Successful CTO Crossing Assessed by Angiography
研究概览
简要总结
To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire.
详细描述
Prospective, multi-center, non-randomized single-arm study of the Wingman Catheter to cross a single infrainguinal peripheral chronic total occlusion (CTO). Safety and effectiveness will be evaluated during the index procedure through 30-day follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 willing and able to provide informed consent.
- •Patient is willing and able to comply with the study protocol.
- •Patient is > 18 years old.
- •Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
- •Patient has at least one but not more than two occluded infrainguinal arteries that are 99-100% stenosed and no flow is observed in the distal lesion except the flow from collateral circulation.
- •Target lesion(s) is ≥ 1 cm and < 30 cm in length by visual estimate.
- •Target vessel is ≥ 2.0 mm in diameter.
- •Patient has Rutherford Classification of 2-
- •Lesion cannot be crossed by concurrent conventional guidewire.
- •Reconstitution of vessel at least 2cm above bifurcation/trifurcation.
- •Occlusion can be within previously implanted stent.
排除标准
- •Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
- •Patient has a known sensitivity or allergy to all anti-platelet medications.
- •Patient is pregnant or lactating.
- •Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
- •Target lesion is in a bypass graft.
- •Patient has had a failed crossing attempt without an intervening intervention on the target limb within the past 14 days.
- •Patient has a planned surgical or interventional procedure within 30 days after the study procedure.
结局指标
主要结局
Number of Lesions With Successful CTO Crossing Assessed by Angiography
时间窗: Intraprocedural
While using the Wingman device, successful CTO crossing is identified by successful guidewire placement in the distal true lumen confirmed by angiography with no clinically significant perforations. Assessment by angiography with results reviewed by an independent core lab.
Major Adverse Event (MAE) Rate
时间窗: Assessed from the time of the procedure through 30 days
Occurrence of significant in-hospital or 30-day MAEs.
Rate of Clinically Significant Perforations
时间窗: Will be assessed from the time of the procedure through 30 days
Occurrence of clinically significant perforation, after Wingman CTO crossing and PTA of lesion, confirmed by angiography, evaluated by angiographic core lab
次要结局
- Lesion Success(Intraprocedural)
- Procedure Success Rate(Approximately 24 hours post procedure)
- Incidence of In-hospital AE or MAE(Intraprocedural)
- Total Procedural Time(Approximately 24 hours post procedure)
- Device Procedural Time(Approximately 24 hours post procedure)
- Contrast Use(Approximately 24 hours post procedure)
- Fluoroscopic Time(Approximately 24 hours post procedure)