NCT01884701撤回3 期
Accessing Peripheral Occluded LesiOns II (APOLO-II)
EndoCross Ltd.0 个研究点开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Advancement of the ENABLER-P supported guidewire into or through the CTO in native femoropopliteal artery and subsequent achievement of distal vessel guidewire position with any conventional guidewire.
研究概览
简要总结
The current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions during endovascular intervention for femoral-popliteal occlusive disease.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation from a previous attempt OR a concurrent reasonable attempt (at least 5 minutes) during this procedure, demonstrating resistance to conventional guidewire crossing;
- •Patient must have objective evidence of lower extremity ischemia;
- •Totally occlusive lesion in a native femoropopliteal artery classified angiographically as absolute (100% occlusion with no flow), where no antegrade filling beyond the occlusion is visible;
- •Target occlusion length is >1cm and ≤ 30 cm;
- •Patient's reference vessel diameter is ≥ 4.0 mm and ≤6.0 mm (by visual angiographic estimation)
- •Patient must be an acceptable candidate for PTA, peripheral artery bypass surgery or peripheral artery stent implantation;
- •Female patients of child bearing potential must have a negative pregnancy test within 48 hours prior to the study procedure;
- •Patient must have been informed of the nature of the study, agree to its provisions, and provide written informed consent;
- •Patient is ≥ 21 years of age.
排除标准
- •Patient has hypersensitivity or contraindication to aspirin, heparin, Plavix or radiographic contrast agents which cannot be adequately pre-medicated;
- •The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels;
- •Patient has planned femoropopliteal intervention scheduled within 30 days after index procedure;
- •The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period;
- •Patient has no collateral flow distal to the occlusion;
- •Patient's target occlusion has a dissection that occurred within the past 30 days caused by a guidewire attempt;
- •Patient has a history of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency;
- •Patient suffered recent (within the past 6 months) significant gastrointestinal (GI) bleeding;
- •Patient's target lesion or the vessel proximal to the target lesion reveals significant ectasia, dissection, aneurysm or thrombus;
- •Patient has other medical illnesses (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with life-expectancy less than 1 year.
结局指标
主要结局
Advancement of the ENABLER-P supported guidewire into or through the CTO in native femoropopliteal artery and subsequent achievement of distal vessel guidewire position with any conventional guidewire.
时间窗: 30 days (+/-7 days)
The primary safety endpoint of this study is to evaluate in hospital and 30 day major adverse events ("MAEs"), clinically significant perforations, clinically significant embolization and/or Grade C or greater dissections.
时间窗: 30 days (+/-7 days)
次要结局
未报告次要终点
研究者
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