NCT02900274已完成不适用
"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes After Plain Old Balloon Angioplasty (POBA) and/or Drug Coated Balloon (DCB) Treatment in the Infra-inguinal Position With the objectiVE to Implant Multiple Stent Segments
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 1
- 主要终点
- target lesion revascularization
研究概览
简要总结
The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA) and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2 & P3)
详细描述
This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to treat flow-limiting dissections/recoil after plain old balloon angioplasty (POBA)/drug coated balloon (DCB) interventions
- •Patients in Rutherford classes 2 through 5
- •Patients eligible for peripheral revascularization by means of percutaneous transluminal angioplasty (PTA) and stenting
- •Patients must be at least 18 years of age
- •Patient with a life expectance of at least 12 months
- •Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol
- •Patients must agree to undergo at least the 6-month clinical follow-up
- •Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of other suitable stent devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
- •Lesions with unsatisfying angiographic results due to recoil and/or dissections after POBA/DCB interventions
- •Infra-inguinal lesions in the superficial femoral artery (SFA) and popliteal segments (P1,P2 & P3) reference vessel diameters between 4 and 7.0 mm, lesion length suitable for the release of at least 2 Stent (up to 6) segments implanted with a minimum inter-stent distance of 1 cm
- •Diameter stenosis pre-procedure must be larger or equal to 70%
- •Vessels must have adequate distal run-off with at least one vessel to the foot or with collaterals in the calf supplying sufficient flow to the foot.
- •(Lesions separated by less than 2 cm are considered as one lesion)
排除标准
- •Patient not suitable for revascularization by interventional means
结局指标
主要结局
target lesion revascularization
时间窗: 6 months
target lesion revascularization surgical \& interventional
次要结局
- maximum walking distance(< 3 weeks, 6 months, 12 months)
- ankle brachial index(< 3 weeks, 6 months, 12 months)
- pain free walking distance(< 3 weeks, 6 months, 12 months)
- quality of life assessment(6 and 12 months)
- target lesion revascularization(12 months)
- procedural success(immediately after Multi-LOC implantation (within the first 30 minutes))
- patency rates(6 and 12 months)
- Rutherford classification(baseline, < 3 weeks, 6 months, 12 months)
- Rutherford classification shift(< 3 weeks, 6 months, 12 months)
- amputation rate(6 and 12 months)
研究者
研究点 (1)
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