NCT00916279已完成1 期
A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents
C. R. Bard11 个研究点 分布在 3 个国家目标入组 41 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 11
- 主要终点
- Percent Diameter Stenosis (%DS) in the Analysis Segment
研究概览
简要总结
The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.
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
- •Male or non-pregnant/non-breast feeding Female ≥18 Years of age. Women of childbearing potential must have a negative pregnancy test within 7 days of the procedure;
- •Documented stable angina pectoris Canadian Cardiovascular Society Classification (CCSC) 1-4, unstable angina pectoris with documented ischemia (Braunwald I-II) or documented silent ischemia;
- •Previous history of native coronary bare metal stenting ≥60 days;
- •LVEF ≥25%;
- •Patient is an acceptable candidate for PTCA, stenting, and emergent CABG;
- •Patient is willing to provide informed consent and comply with follow-up visits and testing schedule;
- •Target lesion is in a native coronary with previous single bare metal stent; Stenosis is ≥50% and <100% by visual estimate or QCA prior to defined pre-dilatation;
- •Reference Vessel Diameter (RVD) is ≥2.5 and ≤3.25;
- •Target lesion is ≤40 mm in length and can be treated in its entirety by no more than 2 contiguous Lutonix Catheters;
- •Guidewire is able to cross lesion(s) and be placed in distal vessel prior to enrollment;
- •Enrollment permitted after successful treatment of 1 to 2 non-study lesions in a single other non-study vessel. Successful treatment is defined as ≤30% residual stenosis with TIMI III flow and no evidence of dissection.
排除标准
- •History of Stroke within past 6 months;
- •History of MI or thrombolysis within 72 hours of randomization;
- •History of previous target vessel perforation;
- •Prior vascular brachytherapy;
- •Angiographic evidence of thrombus or dissection within the target vessel;
- •Intervention of another coronary lesion <60 days before index procedure day or planned following index procedure;
- •Target lesion is in the Left Main or vessel ostium and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥2.5 mm;
- •Target lesion is planned to be treated with something other than PTCA (i.e. stent, cutting balloon, atherectomy, VBT, etc.);
- •Uncontrollable allergies to procedure medications, materials, or contrast;
- •Patient has previous stent procedure with any drug-coated or drug eluting stent device in the target coronary vessel;
- •Known sensitivity to paclitaxel or other antimitogenic agent;
- •Patient has a stent sandwich (a stench previously deployed within another stent;
- •Pre-procedure CKMB >2x ULN or positive Troponin;
- •Creatinine >2.0 mg/dl;
- •Leukocyte <3500/mL;
- •Platelet <100,000 mL or >750,000 mL;
- •Currently taking or must resume warfarin;
- •Patient is contraindicated for anti-platelet therapy or it will need to be withdrawn for a planned procedure;
- •The patient is currently participating in another investigational drug or device study that has not completed its primary endpoint or that clinically interferes with the endpoints of this study;
结局指标
主要结局
Percent Diameter Stenosis (%DS) in the Analysis Segment
时间窗: 6 months
Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months
时间窗: 6 Months
Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.
次要结局
- Late Lumen Loss(6 months)
- MACE Rate(30 Days)
- Binary Restenosis(6 Months)
研究者
研究点 (11)
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