A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 30
- 主要终点
- CTO Crossing Success Using the Wildcat
研究概览
简要总结
This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated during the index procedure through 30-day follow-up.
详细描述
Patients with a CTO, defined as 99% to 100% stenosis of a peripheral artery, will be approached for enrollment in the study. Following providing informed consent, the CTO will be addressed by the Wildcat catheter, which will provide a route for the advancement of guidewires and other tools beyond the CTO. Data will be collected to assess the safety efficacy of use of the device during the procedure and up to 30 days post-procedure.
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
- 19 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 an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate.
- •Target femoropopliteal vessel is ≥ 3.0 mm in diameter.
- •Patient has Rutherford Classification of 2-5.
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 anti-platelet medications.
- •Patient is pregnant or lactating.
- •Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
- •Target vessel is severely calcified as evidenced by angiography.
- •Target lesion is in a bypass graft.
- •Target lesion is in a stent (i.e., in-stent restenosis).
- •Patient has had a procedure on the target limb within 7 days.
- •Patient has had a procedure on the target limb within the past 30 days and is unstable.
- •Patient is simultaneously participating in an investigational device or drug study.
- •Patient has a planned surgical or interventional procedure within 30 days after the study procedure.
结局指标
主要结局
CTO Crossing Success Using the Wildcat
时间窗: Index through 30-Day Follow-Up
Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.
Major Adverse Events
时间窗: Index through 30-Day Follow-Up
The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.
次要结局
未报告次要终点