NCT02460042已完成不适用
CONSEQUENT ALL COMERS Clinical PMCF on Peripheral Arteries Treated With SeQuent® Please OTW Paclitaxel Coated Balloon Catheter in an All Comer Patient Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 960
- 试验地点
- 2
- 主要终点
- Target Lesion Revascularization Rate
研究概览
简要总结
The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries. It is the intention of this trial to treat suitable target lesions with drug coated balloon (DCB) only.
详细描述
This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=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 the target lesion according to the DCB only concept
- •Patients in Rutherford classes 2 through 5
- •Patients eligible for peripheral revascularization by means of Percutaneous Transluminal Angioplasty (PTA)
- •Patients must be 18 years of age
- •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 12-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 the paclitaxel-eluting PTA-balloon catheter or other suitable devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
- •Inclusion Criteria (lesion):
- •Peripheral lesions in peripheral arteries above and below the knee with reference vessel diameters between 1.5 and 8.0 mm, lesion lengths ≥ 2 cm and ≤ 27 cm as angiographically documented*
- •Diameter stenosis pre-procedure must be 70%
- •Target lesion above and below the knee
- •Vessels must have adequate runoff with at least one vessel to the foot. *Lesions separated by less than 2 cm are considered as one lesion
排除标准
- •(all comers):
- •Patient not suitable for revascularization by interventional means
结局指标
主要结局
Target Lesion Revascularization Rate
时间窗: 12 months
rate of target lesion revascularization (interventional, surgical)
次要结局
- Procedural success(1 day)
- Rutherford classification distribution change at all follow-up intervals(12/24 months and 3/5 years)
- Target Lesion Revascularization Rate (TLR)(24 months)
- Ankle Brachial Index (ABI)(5 years)
- Rutherford classifications per group at all follow-up intervals(12/24 months and 3/5 years)
- Amputation rate(12/24 months and 3/5 years)
- Patency rate(5 years)
- Maximum Walking Distance (MWD)(5 years)
- Ankle Brachial Index (ABI)(12 months)
- Ankle Brachial Index (ABI)(24 months)
- Ankle Brachial Index (ABI)(3 years)
- Maximum Walking Distance (MWD)(12 months)
- Maximum Walking Distance (MWD)(24 months)
- Maximum Walking Distance (MWD)(3 years)
- Patency rate(12 months)
- Patency rate(24 months)
- Patency rate(3 years)
研究者
研究点 (2)
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